<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02258542</url>
  </required_header>
  <id_info>
    <org_study_id>D3250C00021</org_study_id>
    <secondary_id>U1111-1162-2422</secondary_id>
    <nct_id>NCT02258542</nct_id>
  </id_info>
  <brief_title>A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA</brief_title>
  <acronym>BORA</acronym>
  <official_title>A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to characterize the safety profile of benralizumab&#xD;
      administration in asthma patients who have completed one of the three predecessor studies:&#xD;
      D3250C00017, D3250C00018 or D3250C00020.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to&#xD;
      a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than&#xD;
      40 weeks, in this study, will be given the option to transition to an open-label safety&#xD;
      extension study, Study D3250C00037 (MELTEMI).&#xD;
&#xD;
      Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to&#xD;
      enter Study D3250C00037 will remain in this study through IPD or EOT and FU.&#xD;
&#xD;
      At the time of the first interim analysis in Japanese patients, the study regimen for all&#xD;
      patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and&#xD;
      blinding at the site and patient level will remain unchanged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2014</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">October 18, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in hematologic lab parameter of Basophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Basophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in chemistry tests ALT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of ALT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in chemistry tests AST.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of AST.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline in chemistry test Bilirubin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline in hematologic lab parameter of Bilirubin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Overall Patients With Asthma Exacerbations During Study Period</measure>
    <time_frame>From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-bronchodilator FEV1 (L)</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-bronchodilator FEV1 (L)</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)</measure>
    <time_frame>Week 56</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Eosinophil Levels' Measurement in Overall Patients</measure>
    <time_frame>Week 56</time_frame>
    <description>Change from baseline to Week 56 in Blood eosinophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).</measure>
    <time_frame>Week 108</time_frame>
    <description>Change from baseline to Week 108 in Blood eosinophils.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ-5D-5L Visual Analog Scale</measure>
    <time_frame>Week 56</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)</measure>
    <time_frame>Week 68</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)</measure>
    <time_frame>Week 56</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)</measure>
    <time_frame>Week 68</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Week 108</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
    <description>Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline and Week 108</time_frame>
    <description>Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study</measure>
    <time_frame>Week 0 and Week 56</time_frame>
    <description>Endpoint: Pharmacokinetic (PK) parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>Baseline and Week 108</time_frame>
    <description>Endpoint: Pharmacokinetic (PK) parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study</measure>
    <time_frame>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</time_frame>
    <description>Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)</measure>
    <time_frame>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</time_frame>
    <description>Assessments for the presence of ADA and nAb throughout study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2133</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Benralizumab Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Benralizumab administered subcutaneously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benralizumab Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Benralizumab administered subcutaneously</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Benralizumab</intervention_name>
    <description>Benralizumab administered subcutaneously</description>
    <arm_group_label>Benralizumab Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Benralizumab</intervention_name>
    <description>Benralizumab administered subcutaneously</description>
    <arm_group_label>Benralizumab Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Informed consent (and/or assent as applicable locally) for study participation must be&#xD;
             obtained prior to any study related procedures being performed (local regulations are&#xD;
             to be followed in determining the assent/consent requirements for children and&#xD;
             parent(s)/guardian(s)) and according to international guidelines and/or applicable&#xD;
             European Union guidelines.&#xD;
&#xD;
          2. Female and male patients who completed the double-blind treatment period in a&#xD;
             predecessor study on benralizumab or matching placebo.&#xD;
&#xD;
          3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth&#xD;
             control throughout the study duration and for 16 weeks after last dose of&#xD;
             Investigational Product (IP).&#xD;
&#xD;
          4. For WOCBP only: Have a negative urine pregnancy test prior to administration of&#xD;
             Investigational Product (IP) at Visit 1.&#xD;
&#xD;
          5. All male patients who are sexually active must agree to use a double barrier method of&#xD;
             contraception (condom with spermicide) from the first dose of IP until 16 weeks after&#xD;
             their last dose.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic,&#xD;
             renal, neurological, musculoskeletal, infectious, endocrine, metabolic,&#xD;
             haematological, psychiatric or major physical impairment that is not stable in the&#xD;
             opinion of the Investigator and could:&#xD;
&#xD;
               -  Affect the safety of the patient throughout the study&#xD;
&#xD;
               -  Influence the findings of the studies or their interpretations&#xD;
&#xD;
               -  Impede the patient's ability to complete the entire duration of study&#xD;
&#xD;
          2. A helminth parasitic infection diagnosed during a predecessor study that has either&#xD;
             not been treated, has been incompletely treated or has failed to respond to standard&#xD;
             of care therapy&#xD;
&#xD;
          3. Any clinically significant change in physical examination, vital signs,&#xD;
             electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a&#xD;
             predecessor study which in the opinion of the investigator may put the patient at risk&#xD;
             because of his/her participation in the study, or may influence the results of the&#xD;
             study, or interfere with the patient's ability to complete the entire duration of the&#xD;
             study&#xD;
&#xD;
          4. Current malignancy or malignancy that developed during a predecessor study (subjects&#xD;
             that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was&#xD;
             resected for cure, or in situ carcinoma of the cervix that has been treated/cured will&#xD;
             not be excluded).&#xD;
&#xD;
          5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in&#xD;
             this study, during the treatment period, and for 16 weeks (5 half-lives) after the&#xD;
             last dose of the investigational product&#xD;
&#xD;
          6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1&#xD;
&#xD;
          7. Planned major surgical procedures during the conduct of the study&#xD;
&#xD;
          8. Previous participation in the present study&#xD;
&#xD;
          9. Concurrent enrolment in another clinical trial&#xD;
&#xD;
         10. AstraZeneca staff involved in the planning and/or conduct of the study&#xD;
&#xD;
         11. Employees of the study centre or any other individuals involved with the conduct of&#xD;
             the study or immediate family members of such individuals&#xD;
&#xD;
         12. Patients with major protocol deviations in any of the predecessor studies at the&#xD;
             discretion of the Sponsor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William W. Busse, M.D., Professor of Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Andalusia</city>
        <state>Alabama</state>
        <zip>36420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsboro</city>
        <state>Alabama</state>
        <zip>35768</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alhambra</city>
        <state>California</state>
        <zip>91801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
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  <location>
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  <location>
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      <name>Research Site</name>
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  <location>
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  <location>
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  <location>
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      <name>Research Site</name>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
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  <location>
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      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
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        <zip>33134</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>33144</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>33176</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
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  <location>
    <facility>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
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      <address>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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        <zip>78006</zip>
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  <location>
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  <location>
    <facility>
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      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
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  <location>
    <facility>
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      <address>
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  <location>
    <facility>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
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        <country>United States</country>
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  <location>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
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  <location>
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      <name>Research Site</name>
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        <city>Málaga</city>
        <zip>29010</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sagunto(Valencia)</city>
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  <location>
    <facility>
      <name>Research Site</name>
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        <city>Salamanca</city>
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      <name>Research Site</name>
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  <location>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Göteborg</city>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Adana</city>
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        <city>Ankara</city>
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    <facility>
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    <facility>
      <name>Research Site</name>
      <address>
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        <zip>34098</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>İstanbul</city>
        <zip>34844</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izmir</city>
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  <location>
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        <zip>CB2 0QQ</zip>
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    <facility>
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        <zip>G12 0YN</zip>
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  <location>
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      <name>Research Site</name>
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        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>NG5 1PB</zip>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Plymouth</city>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Soham</city>
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  <location>
    <facility>
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  <location>
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        <city>Hanoi</city>
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        <country>Vietnam</country>
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      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh</city>
        <zip>700000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=2560&amp;filename=D3250C00021_Revised_CSP_3_16Dec2016_Redacted.pdf</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=2560&amp;filename=D3250C00021_SAP_Edition_3_11_Dec2017_Redacted.pdf</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=2560&amp;filename=BORA_clinical_study_protocol-redacted.pdf</url>
    <description>BORA clinical study protocol-redacted</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>October 18, 2018</results_first_submitted>
  <results_first_submitted_qc>January 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 6, 2019</results_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Benralizumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02258542/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02258542/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>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.</recruitment_details>
      <pre_assignment_details>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.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 weeks</description>
        </group>
        <group group_id="P3">
          <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 weeks</description>
        </group>
        <group group_id="P4">
          <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="953"/>
                <participants group_id="P2" count="973"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="953"/>
                <participants group_id="P2" count="971"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Adolescents Only</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="911">170 enrolled into study MELTEMI</participants>
                <participants group_id="P2" count="924">178 enrolled into study MELTEMI</participants>
                <participants group_id="P3" count="92">51 enrolled into study MELTEMI</participants>
                <participants group_id="P4" count="92">48 enrolled into study MELTEMI</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>eg. not made to the visit</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>study specific discount. criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility criteria not fulfilled</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis population defined as treated for at least 1 treatment, excluding patients enrolled in MELTEMI.</population>
      <group_list>
        <group group_id="B1">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 weeks</description>
        </group>
        <group group_id="B3">
          <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 weeks</description>
        </group>
        <group group_id="B4">
          <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 weeks</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="783"/>
            <count group_id="B2" value="793"/>
            <count group_id="B3" value="49"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="1674"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Full analysis set, excluding MELTEMI patients</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.1" spread="13.79"/>
                    <measurement group_id="B2" value="48.9" spread="15.53"/>
                    <measurement group_id="B3" value="49.7" spread="10.35"/>
                    <measurement group_id="B4" value="52.7" spread="8.90"/>
                    <measurement group_id="B5" value="50.1" spread="14.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Full analysis set, exclude MELTEMI patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="503"/>
                    <measurement group_id="B2" value="470"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="1029"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="280"/>
                    <measurement group_id="B2" value="323"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Full analysis set</population>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="599"/>
                    <measurement group_id="B2" value="612"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="1298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black and African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in hematologic lab parameter of Basophils.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in hematologic lab parameter of Basophils.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="691"/>
                <count group_id="O2" value="703"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.0223"/>
                    <measurement group_id="O2" value="-0.005" spread="0.0239"/>
                    <measurement group_id="O3" value="-0.007" spread="0.0283"/>
                    <measurement group_id="O4" value="-0.005" spread="0.0244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Basophils.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Basophils.</description>
          <population>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.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.0145"/>
                    <measurement group_id="O2" value="0.001" spread="0.0208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="695"/>
                <count group_id="O2" value="710"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.344" spread="2.0412"/>
                    <measurement group_id="O2" value="-0.128" spread="1.8614"/>
                    <measurement group_id="O3" value="-0.808" spread="1.8177"/>
                    <measurement group_id="O4" value="-0.507" spread="3.3612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Leukocytes.</description>
          <population>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.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.487" spread="1.7289"/>
                    <measurement group_id="O2" value="-0.079" spread="1.8432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="691"/>
                <count group_id="O2" value="703"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.032" spread="0.6242"/>
                    <measurement group_id="O2" value="0.003" spread="0.5402"/>
                    <measurement group_id="O3" value="-0.093" spread="0.6403"/>
                    <measurement group_id="O4" value="0.007" spread="0.6864"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Lymphocytes.</description>
          <population>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.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.180" spread="0.6946"/>
                    <measurement group_id="O2" value="-0.070" spread="0.6671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="691"/>
                <count group_id="O2" value="703"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.171" spread="1.8746"/>
                    <measurement group_id="O2" value="0.013" spread="1.7024"/>
                    <measurement group_id="O3" value="-0.501" spread="1.7096"/>
                    <measurement group_id="O4" value="-0.368" spread="3.2057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Neutrophils.</description>
          <population>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.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.451" spread="1.7645"/>
                    <measurement group_id="O2" value="0.242" spread="1.8469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="691"/>
                <count group_id="O2" value="703"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1220" spread="0.30599"/>
                    <measurement group_id="O2" value="-0.1271" spread="0.26161"/>
                    <measurement group_id="O3" value="-0.1451" spread="0.30766"/>
                    <measurement group_id="O4" value="-0.1664" spread="0.35139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Eosinophils.</description>
          <population>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.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1294" spread="0.27973"/>
                    <measurement group_id="O2" value="-0.1838" spread="0.3381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in chemistry tests ALT.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in chemistry tests ALT.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>ukat/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="684"/>
                <count group_id="O2" value="712"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.2102"/>
                    <measurement group_id="O2" value="0.017" spread="0.4651"/>
                    <measurement group_id="O3" value="-0.064" spread="0.3547"/>
                    <measurement group_id="O4" value="-0.023" spread="0.1940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of ALT.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of ALT.</description>
          <population>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.</population>
          <units>ukat/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.048" spread="0.2195"/>
                    <measurement group_id="O2" value="0.034" spread="0.2312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in chemistry tests AST.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in chemistry tests AST.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>ukat/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="684"/>
                <count group_id="O2" value="712"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.1431"/>
                    <measurement group_id="O2" value="0.004" spread="0.3303"/>
                    <measurement group_id="O3" value="-0.027" spread="0.2291"/>
                    <measurement group_id="O4" value="-0.026" spread="0.1178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of AST.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of AST.</description>
          <population>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.</population>
          <units>ukat/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.1196"/>
                    <measurement group_id="O2" value="-0.013" spread="0.1297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients</title>
        <description>Change from baseline in chemistry test Bilirubin.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients</title>
          <description>Change from baseline in chemistry test Bilirubin.</description>
          <population>Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="685"/>
                <count group_id="O2" value="712"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.187" spread="3.6261"/>
                    <measurement group_id="O2" value="0.391" spread="3.9945"/>
                    <measurement group_id="O3" value="0.146" spread="2.8094"/>
                    <measurement group_id="O4" value="0.279" spread="3.8765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline in hematologic lab parameter of Bilirubin.</description>
        <time_frame>Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline in hematologic lab parameter of Bilirubin.</description>
          <population>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.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.221" spread="8.3453"/>
                    <measurement group_id="O2" value="0.202" spread="3.6575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Overall Patients With Asthma Exacerbations During Study Period</title>
        <description>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</description>
        <time_frame>From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O9">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O10">
            <title>ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O11">
            <title>ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O12">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Overall Patients With Asthma Exacerbations During Study Period</title>
          <description>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</description>
          <population>Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="518"/>
                <count group_id="O2" value="265"/>
                <count group_id="O3" value="783"/>
                <count group_id="O4" value="512"/>
                <count group_id="O5" value="281"/>
                <count group_id="O6" value="793"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="18"/>
                <count group_id="O9" value="49"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="18"/>
                <count group_id="O12" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="347"/>
                    <count group_id="O2" value="172"/>
                    <count group_id="O3" value="519"/>
                    <count group_id="O4" value="339"/>
                    <count group_id="O5" value="188"/>
                    <count group_id="O6" value="527"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of exacerbation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="159"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="66"/>
                    <measurement group_id="O6" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="264"/>
                    <count group_id="O4" value="173"/>
                    <count group_id="O5" value="93"/>
                    <count group_id="O6" value="266"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of exacerbation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="113"/>
                    <measurement group_id="O4" value="65"/>
                    <measurement group_id="O5" value="32"/>
                    <measurement group_id="O6" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zonda Patients with asthma exacerbations</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="31"/>
                    <count group_id="O8" value="18"/>
                    <count group_id="O9" value="49"/>
                    <count group_id="O10" value="31"/>
                    <count group_id="O11" value="18"/>
                    <count group_id="O12" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of exacerbation</title>
                  <measurement_list>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="17"/>
                    <measurement group_id="O10" value="13"/>
                    <measurement group_id="O11" value="11"/>
                    <measurement group_id="O12" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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</description>
        <time_frame>From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of exacerbation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="15"/>
                    <count group_id="O6" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of exacerbation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-bronchodilator FEV1 (L)</title>
        <description>Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O9">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O10">
            <title>ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O11">
            <title>ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O12">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-bronchodilator FEV1 (L)</title>
          <description>Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="444"/>
                <count group_id="O2" value="221"/>
                <count group_id="O3" value="665"/>
                <count group_id="O4" value="440"/>
                <count group_id="O5" value="220"/>
                <count group_id="O6" value="660"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="18"/>
                <count group_id="O9" value="38"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="15"/>
                <count group_id="O12" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="142"/>
                    <count group_id="O3" value="439"/>
                    <count group_id="O4" value="291"/>
                    <count group_id="O5" value="151"/>
                    <count group_id="O6" value="442"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.295"/>
                    <measurement group_id="O2" value="0.131" spread="0.422"/>
                    <measurement group_id="O3" value="0.038" spread="0.346"/>
                    <measurement group_id="O4" value="0.019" spread="0.317"/>
                    <measurement group_id="O5" value="0.081" spread="0.419"/>
                    <measurement group_id="O6" value="0.040" spread="0.356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="226"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="69"/>
                    <count group_id="O6" value="218"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.021" spread="0.376"/>
                    <measurement group_id="O2" value="-0.011" spread="0.280"/>
                    <measurement group_id="O3" value="-0.017" spread="0.345"/>
                    <measurement group_id="O4" value="-0.015" spread="0.293"/>
                    <measurement group_id="O5" value="0.030" spread="0.350"/>
                    <measurement group_id="O6" value="-0.001" spread="0.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="31"/>
                    <count group_id="O8" value="18"/>
                    <count group_id="O9" value="38"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="15"/>
                    <count group_id="O12" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="0.013" spread="0.354"/>
                    <measurement group_id="O8" value="0.167" spread="0.533"/>
                    <measurement group_id="O9" value="0.057" spread="0.412"/>
                    <measurement group_id="O10" value="-0.093" spread="0.280"/>
                    <measurement group_id="O11" value="0.138" spread="0.329"/>
                    <measurement group_id="O12" value="-0.012" spread="0.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.205" spread="0.289"/>
                    <measurement group_id="O2" value="-0.189" spread="0.354"/>
                    <measurement group_id="O3" value="-0.020" spread="0.375"/>
                    <measurement group_id="O4" value="0.578" spread="0.608"/>
                    <measurement group_id="O5" value="0.413" spread="0.375"/>
                    <measurement group_id="O6" value="0.496" spread="0.502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.325" spread="0.431"/>
                    <measurement group_id="O2" value="1.140" spread="NA">Only 1 participants, not able to calculate Standard deviation.</measurement>
                    <measurement group_id="O3" value="0.597" spread="0.561"/>
                    <measurement group_id="O4" value="0.047" spread="0.340"/>
                    <measurement group_id="O5" value="0.240" spread="0.519"/>
                    <measurement group_id="O6" value="0.147" spread="0.444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-bronchodilator FEV1 (L)</title>
        <description>Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-bronchodilator FEV1 (L)</title>
          <description>Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
          <population>Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized.</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="439"/>
                <count group_id="O2" value="220"/>
                <count group_id="O3" value="659"/>
                <count group_id="O4" value="438"/>
                <count group_id="O5" value="214"/>
                <count group_id="O6" value="652"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="440"/>
                    <count group_id="O4" value="292"/>
                    <count group_id="O5" value="151"/>
                    <count group_id="O6" value="443"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.066" spread="0.280"/>
                    <measurement group_id="O2" value="0.089" spread="0.455"/>
                    <measurement group_id="O3" value="-0.015" spread="0.354"/>
                    <measurement group_id="O4" value="-0.029" spread="0.281"/>
                    <measurement group_id="O5" value="0.045" spread="0.401"/>
                    <measurement group_id="O6" value="-0.004" spread="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="219"/>
                    <count group_id="O4" value="146"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.058" spread="0.379"/>
                    <measurement group_id="O2" value="-0.024" spread="0.289"/>
                    <measurement group_id="O3" value="-0.046" spread="0.350"/>
                    <measurement group_id="O4" value="-0.043" spread="0.273"/>
                    <measurement group_id="O5" value="0.049" spread="0.394"/>
                    <measurement group_id="O6" value="-0.015" spread="0.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.062" spread="0.537"/>
                    <measurement group_id="O2" value="-0.305" spread="0.394"/>
                    <measurement group_id="O3" value="-0.201" spread="0.458"/>
                    <measurement group_id="O4" value="0.603" spread="0.749"/>
                    <measurement group_id="O5" value="0.279" spread="0.659"/>
                    <measurement group_id="O6" value="0.448" spread="0.712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.375" spread="0.474"/>
                    <measurement group_id="O2" value="0.880" spread="NA">Only 1 participants, not able to calculate SD</measurement>
                    <measurement group_id="O3" value="0.543" spread="0.444"/>
                    <measurement group_id="O4" value="-0.006" spread="0.327"/>
                    <measurement group_id="O5" value="0.218" spread="0.536"/>
                    <measurement group_id="O6" value="0.111" spread="0.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients</title>
        <description>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.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O9">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O10">
            <title>ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O11">
            <title>ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O12">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients</title>
          <description>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.</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="447"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="671"/>
                <count group_id="O4" value="444"/>
                <count group_id="O5" value="220"/>
                <count group_id="O6" value="664"/>
                <count group_id="O7" value="28"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="39"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="15"/>
                <count group_id="O12" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="298"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="444"/>
                    <count group_id="O4" value="294"/>
                    <count group_id="O5" value="153"/>
                    <count group_id="O6" value="447"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.83"/>
                    <measurement group_id="O2" value="-0.20" spread="1.04"/>
                    <measurement group_id="O3" value="-0.09" spread="0.91"/>
                    <measurement group_id="O4" value="-0.06" spread="0.82"/>
                    <measurement group_id="O5" value="-0.25" spread="1.06"/>
                    <measurement group_id="O6" value="-0.12" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="227"/>
                    <count group_id="O4" value="150"/>
                    <count group_id="O5" value="67"/>
                    <count group_id="O6" value="217"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.90"/>
                    <measurement group_id="O2" value="-0.12" spread="0.80"/>
                    <measurement group_id="O3" value="-0.15" spread="0.86"/>
                    <measurement group_id="O4" value="-0.10" spread="0.83"/>
                    <measurement group_id="O5" value="-0.09" spread="1.06"/>
                    <measurement group_id="O6" value="-0.10" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="28"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="39"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="15"/>
                    <count group_id="O12" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="-0.05" spread="0.89"/>
                    <measurement group_id="O8" value="-0.61" spread="0.74"/>
                    <measurement group_id="O9" value="-0.21" spread="0.87"/>
                    <measurement group_id="O10" value="0.15" spread="1.02"/>
                    <measurement group_id="O11" value="-0.43" spread="1.00"/>
                    <measurement group_id="O12" value="-0.05" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.53"/>
                    <measurement group_id="O2" value="0.06" spread="0.49"/>
                    <measurement group_id="O3" value="0.16" spread="0.50"/>
                    <measurement group_id="O4" value="-0.14" spread="0.51"/>
                    <measurement group_id="O5" value="-0.10" spread="1.38"/>
                    <measurement group_id="O6" value="-0.12" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="0.24"/>
                    <measurement group_id="O2" value="-1.83" spread="NA">Only one participant, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="0.94" spread="0.79"/>
                    <measurement group_id="O4" value="-0.21" spread="0.78"/>
                    <measurement group_id="O5" value="-0.21" spread="0.77"/>
                    <measurement group_id="O6" value="-0.21" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)</title>
        <description>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.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O9">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O10">
            <title>ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O11">
            <title>ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O12">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)</title>
          <description>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.</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="444"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="668"/>
                <count group_id="O4" value="442"/>
                <count group_id="O5" value="220"/>
                <count group_id="O6" value="662"/>
                <count group_id="O7" value="26"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="37"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="15"/>
                <count group_id="O12" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="442"/>
                    <count group_id="O4" value="293"/>
                    <count group_id="O5" value="153"/>
                    <count group_id="O6" value="446"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.80"/>
                    <measurement group_id="O2" value="0.21" spread="0.98"/>
                    <measurement group_id="O3" value="0.08" spread="0.87"/>
                    <measurement group_id="O4" value="0.08" spread="0.91"/>
                    <measurement group_id="O5" value="0.26" spread="1.00"/>
                    <measurement group_id="O6" value="0.15" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="226"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="67"/>
                    <count group_id="O6" value="216"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.84"/>
                    <measurement group_id="O2" value="0.03" spread="0.89"/>
                    <measurement group_id="O3" value="0.09" spread="0.85"/>
                    <measurement group_id="O4" value="0.15" spread="0.90"/>
                    <measurement group_id="O5" value="0.02" spread="1.06"/>
                    <measurement group_id="O6" value="0.11" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="26"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="37"/>
                    <count group_id="O10" value="28"/>
                    <count group_id="O11" value="15"/>
                    <count group_id="O12" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="0.13" spread="0.93"/>
                    <measurement group_id="O8" value="0.43" spread="0.91"/>
                    <measurement group_id="O9" value="0.22" spread="0.92"/>
                    <measurement group_id="O10" value="-0.04" spread="0.94"/>
                    <measurement group_id="O11" value="0.40" spread="1.03"/>
                    <measurement group_id="O12" value="0.11" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="1.22"/>
                    <measurement group_id="O2" value="-0.11" spread="0.21"/>
                    <measurement group_id="O3" value="0.25" spread="0.92"/>
                    <measurement group_id="O4" value="0.52" spread="0.37"/>
                    <measurement group_id="O5" value="0.06" spread="0.59"/>
                    <measurement group_id="O6" value="0.29" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.55"/>
                    <measurement group_id="O2" value="1.53" spread="NA">Only one participants, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="0.94" spread="0.65"/>
                    <measurement group_id="O4" value="0.58" spread="1.01"/>
                    <measurement group_id="O5" value="0.27" spread="0.77"/>
                    <measurement group_id="O6" value="0.42" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Blood Eosinophil Levels' Measurement in Overall Patients</title>
        <description>Change from baseline to Week 56 in Blood eosinophils</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O9">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O10">
            <title>ZONDA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O11">
            <title>ZONDA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O12">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Blood Eosinophil Levels' Measurement in Overall Patients</title>
          <description>Change from baseline to Week 56 in Blood eosinophils</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups.</population>
          <units>cell/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="454"/>
                <count group_id="O2" value="237"/>
                <count group_id="O3" value="691"/>
                <count group_id="O4" value="461"/>
                <count group_id="O5" value="242"/>
                <count group_id="O6" value="703"/>
                <count group_id="O7" value="28"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="39"/>
                <count group_id="O10" value="27"/>
                <count group_id="O11" value="15"/>
                <count group_id="O12" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="462"/>
                    <count group_id="O4" value="302"/>
                    <count group_id="O5" value="162"/>
                    <count group_id="O6" value="464"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="177.42"/>
                    <measurement group_id="O2" value="-449.6" spread="360.6"/>
                    <measurement group_id="O3" value="-148.6" spread="332.91"/>
                    <measurement group_id="O4" value="-10.1" spread="134.7"/>
                    <measurement group_id="O5" value="-422.5" spread="330.01"/>
                    <measurement group_id="O6" value="-154.1" spread="297.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="229"/>
                    <count group_id="O4" value="159"/>
                    <count group_id="O5" value="80"/>
                    <count group_id="O6" value="239"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                    <count group_id="O11" value="0"/>
                    <count group_id="O12" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" spread="87.04"/>
                    <measurement group_id="O2" value="-222.1" spread="325.03"/>
                    <measurement group_id="O3" value="-68.4" spread="234.40"/>
                    <measurement group_id="O4" value="-2.9" spread="59.11"/>
                    <measurement group_id="O5" value="-217.4" spread="198.56"/>
                    <measurement group_id="O6" value="-74.7" spread="160.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="28"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="39"/>
                    <count group_id="O10" value="27"/>
                    <count group_id="O11" value="15"/>
                    <count group_id="O12" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O7" value="2.5" spread="69.85"/>
                    <measurement group_id="O8" value="-520.9" spread="360.79"/>
                    <measurement group_id="O9" value="-145.1" spread="307.66"/>
                    <measurement group_id="O10" value="-17.0" spread="107.48"/>
                    <measurement group_id="O11" value="-435.3" spread="468.64"/>
                    <measurement group_id="O12" value="-166.4" spread="351.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).</title>
        <description>Change from baseline to Week 108 in Blood eosinophils.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).</title>
          <description>Change from baseline to Week 108 in Blood eosinophils.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>cell/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" spread="192.19"/>
                    <measurement group_id="O2" value="-356.7" spread="215.47"/>
                    <measurement group_id="O3" value="-139.2" spread="299.16"/>
                    <measurement group_id="O4" value="-163.6" spread="502.76"/>
                    <measurement group_id="O5" value="-332.9" spread="349.89"/>
                    <measurement group_id="O6" value="-229.4" spread="446.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160.0" spread="NA">Only one participants, not able to calculate SD.</measurement>
                    <measurement group_id="O2" value="-150.0" spread="NA">Only one participants, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="5.0" spread="219.20"/>
                    <measurement group_id="O4" value="-2.0" spread="9.19"/>
                    <measurement group_id="O5" value="-204.4" spread="152.32"/>
                    <measurement group_id="O6" value="-97.9" spread="145.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ-5D-5L Visual Analog Scale</title>
        <description>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.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ-5D-5L Visual Analog Scale</title>
          <description>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.</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="682"/>
                <count group_id="O2" value="709"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="454"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="15.68"/>
                    <measurement group_id="O2" value="6.02" spread="17.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                    <count group_id="O2" value="241"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" spread="14.99"/>
                    <measurement group_id="O2" value="6.69" spread="15.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="5.00" spread="10.35"/>
                    <measurement group_id="O4" value="1.36" spread="13.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="24"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.43" spread="9.73"/>
                    <measurement group_id="O2" value="6.63" spread="15.53"/>
                    <measurement group_id="O3" value="6.07" spread="12.71"/>
                    <measurement group_id="O4" value="11.54" spread="26.95"/>
                    <measurement group_id="O5" value="9.83" spread="13.87"/>
                    <measurement group_id="O6" value="10.72" spread="21.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.00" spread="12.73"/>
                    <measurement group_id="O2" value="-4.00" spread="NA">Only one participants, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="13.33" spread="17.50"/>
                    <measurement group_id="O4" value="10.18" spread="32.69"/>
                    <measurement group_id="O5" value="5.08" spread="10.45"/>
                    <measurement group_id="O6" value="7.52" spread="23.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)</title>
        <description>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.</description>
        <time_frame>Week 68</time_frame>
        <population>Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)</title>
          <description>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.</description>
          <population>Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="349"/>
                <count group_id="O2" value="313"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="236"/>
                    <count group_id="O2" value="217"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="26.18"/>
                    <measurement group_id="O2" value="21.0" spread="25.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="96"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" spread="27.55"/>
                    <measurement group_id="O2" value="25.8" spread="24.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zonda Patients-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="18.9" spread="24.94"/>
                    <measurement group_id="O4" value="21.0" spread="27.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="10.0" spread="NA">Only one participant, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="3" spread="3.3"/>
                    <measurement group_id="O4" value="20.0" spread="NA">Only one participant, not able to calculate SD.</measurement>
                    <measurement group_id="O5" value="10.0" spread="NA">Only one participant, not able to calculate SD.</measurement>
                    <measurement group_id="O6" value="15.0" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk-108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0.0" spread="0.00"/>
                    <measurement group_id="O5" value="13.3" spread="5.77"/>
                    <measurement group_id="O6" value="8.0" spread="8.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)</title>
        <description>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.</description>
        <time_frame>Week 56</time_frame>
        <population>Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)</title>
          <description>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.</description>
          <population>Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="7.44"/>
                    <measurement group_id="O2" value="15.2" spread="20.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="7.07"/>
                    <measurement group_id="O2" value="17.1" spread="20.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zonda patients-wk 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="6.82"/>
                    <measurement group_id="O2" value="15.2" spread="17.55"/>
                    <measurement group_id="O3" value="9.5" spread="12.98"/>
                    <measurement group_id="O4" value="5.4" spread="8.32"/>
                    <measurement group_id="O5" value="18.6" spread="27.94"/>
                    <measurement group_id="O6" value="12.3" spread="21.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk-108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="30.41"/>
                    <measurement group_id="O3" value="21.5" spread="30.41"/>
                    <measurement group_id="O4" value="12.5" spread="18.10"/>
                    <measurement group_id="O5" value="10.6" spread="11.68"/>
                    <measurement group_id="O6" value="11.5" spread="14.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)</title>
        <description>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.</description>
        <time_frame>Week 68</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)</title>
          <description>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.</description>
          <population>Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count &gt;=300/uL or &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="697"/>
                <count group_id="O2" value="674"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="458"/>
                    <count group_id="O2" value="454"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="26.14"/>
                    <measurement group_id="O2" value="24.4" spread="25.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="220"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" spread="26.55"/>
                    <measurement group_id="O2" value="32.7" spread="26.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zonda Patients-wk 68</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="38"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="28.4" spread="27.85"/>
                    <measurement group_id="O4" value="39.0" spread="34.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</title>
        <description>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.</description>
        <time_frame>Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)</title>
          <description>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.</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL-wk 108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="11.13"/>
                    <measurement group_id="O2" value="5.0" spread="9.26"/>
                    <measurement group_id="O3" value="6.0" spread="9.86"/>
                    <measurement group_id="O4" value="5.4" spread="8.77"/>
                    <measurement group_id="O5" value="19.2" spread="24.31"/>
                    <measurement group_id="O6" value="12.3" spread="19.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL-wk-108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="14.14"/>
                    <measurement group_id="O2" value="20.0" spread="NA">Only one participant, not able to calculate SD.</measurement>
                    <measurement group_id="O3" value="13.3" spread="11.55"/>
                    <measurement group_id="O4" value="14.2" spread="18.81"/>
                    <measurement group_id="O5" value="11.5" spread="10.68"/>
                    <measurement group_id="O6" value="12.8" spread="14.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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</title>
        <description>Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma</description>
        <time_frame>From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)</time_frame>
        <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>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</title>
          <description>Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma</description>
          <population>Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count&gt;=300/uL, and &lt;300/uL; all patients enrolled from ZONDA.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="783"/>
                <count group_id="O2" value="793"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="519"/>
                    <count group_id="O2" value="527"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="264"/>
                    <count group_id="O2" value="266"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Zonda Patients</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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)</title>
        <description>Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma</description>
        <time_frame>Baseline and Week 108</time_frame>
        <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O5">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O6">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>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)</title>
          <description>Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma</description>
          <population>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 &gt;=300/uL or &lt;300/uL; separated by predecessor treatment groups.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sirocco/Calima patients with eos&gt;=300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sirocco/Calima patients with eos&lt;300/μL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="15"/>
                    <count group_id="O6" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study</title>
        <description>Endpoint: Pharmacokinetic (PK) parameters</description>
        <time_frame>Week 0 and Week 56</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O5">
            <title>ZONDA - Benra 30 mg q.4 Weeks - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O6">
            <title>ZONDA - Benra 30 mg q.4 wk - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O7">
            <title>ZONDA - Benra 30 mg q.8 Weeks - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O8">
            <title>ZONDA - Benra 30 mg q.8 wk - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study</title>
          <description>Endpoint: Pharmacokinetic (PK) parameters</description>
          <population>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.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="514"/>
                <count group_id="O2" value="263"/>
                <count group_id="O3" value="511"/>
                <count group_id="O4" value="279"/>
                <count group_id="O5" value="31"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="507"/>
                    <count group_id="O2" value="260"/>
                    <count group_id="O3" value="503"/>
                    <count group_id="O4" value="275"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="30"/>
                    <count group_id="O8" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="714.25" lower_limit="624.48" upper_limit="816.93"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Concentration &lt;LLOQ (Lower Limit of Quantification)</measurement>
                    <measurement group_id="O3" value="142.92" lower_limit="124.08" upper_limit="164.63"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Concentration &lt;LLOQ</measurement>
                    <measurement group_id="O5" value="964.21" lower_limit="589.87" upper_limit="1576.11"/>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">Concentration &lt;LLOQ</measurement>
                    <measurement group_id="O7" value="692.91" lower_limit="428.49" upper_limit="1120.50"/>
                    <measurement group_id="O8" value="NA" lower_limit="NA" upper_limit="NA">Concentration &lt;LLOQ</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="442"/>
                    <count group_id="O2" value="225"/>
                    <count group_id="O3" value="440"/>
                    <count group_id="O4" value="215"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="27"/>
                    <count group_id="O8" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="930.04" lower_limit="825.89" upper_limit="1047.33"/>
                    <measurement group_id="O2" value="865.93" lower_limit="721.50" upper_limit="1039.27"/>
                    <measurement group_id="O3" value="173.95" lower_limit="151.81" upper_limit="199.33"/>
                    <measurement group_id="O4" value="162.03" lower_limit="132.31" upper_limit="195.43"/>
                    <measurement group_id="O5" value="823.62" lower_limit="476.98" upper_limit="1422.17"/>
                    <measurement group_id="O6" value="1160.58" lower_limit="833.77" upper_limit="1615.49"/>
                    <measurement group_id="O7" value="247.26" lower_limit="165.87" upper_limit="368.57"/>
                    <measurement group_id="O8" value="139.35" lower_limit="61.90" upper_limit="313.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Endpoint: Pharmacokinetic (PK) parameters</description>
        <time_frame>Baseline and Week 108</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Pre Benra q.4</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 4 weeks, predecessor study with placebo treatment</description>
          </group>
          <group group_id="O3">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Pre Benra q.8</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with benralizumab treatment</description>
          </group>
          <group group_id="O4">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 - Predecessor Placebo</title>
            <description>Benralizumab administered subcutaneously every 8 weeks, predecessor study with placebo treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Endpoint: Pharmacokinetic (PK) parameters</description>
          <population>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.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="725.55" lower_limit="231.38" upper_limit="2275.13"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">PK concentration &lt;LLOQ (Lower limit of quantification)</measurement>
                    <measurement group_id="O3" value="218.53" lower_limit="126.53" upper_limit="377.42"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">PK concentration &lt;LLOQ</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 108</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="25"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383.73" lower_limit="30.90" upper_limit="4764.79"/>
                    <measurement group_id="O2" value="853.51" lower_limit="260.26" upper_limit="2799.03"/>
                    <measurement group_id="O3" value="436.85" lower_limit="185.36" upper_limit="1029.59"/>
                    <measurement group_id="O4" value="524.39" lower_limit="287.72" upper_limit="955.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study</title>
        <description>Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study</description>
        <time_frame>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</time_frame>
        <population>Full analysis set, excluding MELTEMI patients.</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
          <group group_id="O3">
            <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O4">
            <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study</title>
          <description>Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study</description>
          <population>Full analysis set, excluding MELTEMI patients.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="783"/>
                <count group_id="O2" value="793"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive at any visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="783"/>
                    <count group_id="O2" value="793"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="93"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Base- and Post-baseline Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Newly Persistently Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable persistently positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Newly treatment-induced positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA treatment boosted positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased in titre</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Only post-baseline positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="789"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Only baseline positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="774"/>
                    <count group_id="O2" value="793"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="783"/>
                    <count group_id="O2" value="793"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="75"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)</title>
        <description>Assessments for the presence of ADA and nAb throughout study</description>
        <time_frame>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</time_frame>
        <population>Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents).</population>
        <group_list>
          <group group_id="O1">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
            <description>Benralizumab administered subcutaneously every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
            <description>Benralizumab administered subcutaneously every 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)</title>
          <description>Assessments for the presence of ADA and nAb throughout study</description>
          <population>Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents).</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Base- and Post-baseline Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Newly Persistently Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable persistently positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Newly treatment-induced positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA treatment boosted positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased in titre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Only post-baseline positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transiently Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Only baseline positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nAb positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>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.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 Weeks</description>
        </group>
        <group group_id="E2">
          <title>SIROCCO/CALIMA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 Weeks</description>
        </group>
        <group group_id="E3">
          <title>ZONDA - Benralizumab 30 mg q.4 Weeks</title>
          <description>Benralizumab administered subcutaneously every 4 Weeks</description>
        </group>
        <group group_id="E4">
          <title>ZONDA - Benralizumab 30 mg q.8 Weeks</title>
          <description>Benralizumab administered subcutaneously every 8 Weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="783"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="793"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="102" subjects_at_risk="783"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="793"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Barrett's oesophagus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Femoral hernia strangulated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Postoperative abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Endocrine test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Jaw cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of thyroid gland</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Chronic myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma stage II</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nasal cavity cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ovarian germ cell teratoma benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Solid pseudopapillary tumour of the pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Colon cancer stage 0</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Large intestine benign neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Osteochondroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Thymoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Lumbosacral radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Vaginal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="40" subjects_affected="36" subjects_at_risk="783"/>
                <counts group_id="E2" events="31" subjects_affected="26" subjects_at_risk="793"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Asthmatic crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Middle lobe syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Status asthmaticus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema nodosum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pemphigoid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urticaria papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="415" subjects_at_risk="783"/>
                <counts group_id="E2" subjects_affected="409" subjects_at_risk="793"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="38" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="783"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="783"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="783"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="783"/>
                <counts group_id="E2" events="13" subjects_affected="5" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="41" subjects_affected="27" subjects_at_risk="783"/>
                <counts group_id="E2" events="35" subjects_affected="30" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="783"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="783"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="66" subjects_affected="50" subjects_at_risk="783"/>
                <counts group_id="E2" events="76" subjects_affected="51" subjects_at_risk="793"/>
                <counts group_id="E3" events="7" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="16" subjects_affected="10" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="95" subjects_affected="61" subjects_at_risk="783"/>
                <counts group_id="E2" events="82" subjects_affected="56" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="46" subjects_affected="27" subjects_at_risk="783"/>
                <counts group_id="E2" events="61" subjects_affected="44" subjects_at_risk="793"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" events="24" subjects_affected="19" subjects_at_risk="783"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="783"/>
                <counts group_id="E2" events="17" subjects_affected="10" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="7" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="783"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="783"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="28" subjects_affected="24" subjects_at_risk="783"/>
                <counts group_id="E2" events="37" subjects_affected="26" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="783"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="783"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="783"/>
                <counts group_id="E2" events="28" subjects_affected="23" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="783"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="186" subjects_affected="124" subjects_at_risk="783"/>
                <counts group_id="E2" events="196" subjects_affected="130" subjects_at_risk="793"/>
                <counts group_id="E3" events="22" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E4" events="19" subjects_affected="13" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="783"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="783"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="793"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="26" subjects_at_risk="783"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="793"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="783"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="54" subjects_affected="38" subjects_at_risk="783"/>
                <counts group_id="E2" events="55" subjects_affected="40" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="783"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="100" subjects_affected="62" subjects_at_risk="783"/>
                <counts group_id="E2" events="76" subjects_affected="53" subjects_at_risk="793"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" events="9" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="783"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="793"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="783"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="783"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="793"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="43" subjects_affected="38" subjects_at_risk="783"/>
                <counts group_id="E2" events="32" subjects_affected="22" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="32" subjects_affected="31" subjects_at_risk="783"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="783"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="793"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>≥ 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.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>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.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ubaldo Martin, Global Clinical Lead Benralizumab</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+1 301 398 0163</phone>
      <email>Ubaldo.Martin@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258542
org study id: D3250C00021
secondary id: U1111-1162-2422
nct id: NCT02258542
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in hematologic lab parameter of Basophils.
measure: Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Basophils.
measure: Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in hematologic lab parameter of Leukocytes.
measure: Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Leukocytes.
measure: Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in hematologic lab parameter of Lymphocytes.
measure: Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Lymphocytes.
measure: Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in hematologic lab parameter of Neutrophils.
measure: Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Neutrophils.
measure: Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in hematologic lab parameter of Eosinophils.
measure: Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Eosinophils.
measure: Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in chemistry tests ALT.
measure: Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of ALT.
measure: Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in chemistry tests AST.
measure: Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of AST.
measure: Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
time frame: Week 56
description: Change from baseline in chemistry test Bilirubin.
measure: Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline in hematologic lab parameter of Bilirubin.
measure: Number of Overall Patients With Asthma Exacerbations During Study Period
time frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
description: 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
measure: Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
time frame: From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
description: 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
measure: Change From Baseline in Pre-bronchodilator FEV1 (L)
time frame: Week 56
description: Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
measure: Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
measure: Change From Baseline in Post-bronchodilator FEV1 (L)
time frame: Week 56
description: Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
measure: Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
time frame: Week 56
description: 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.
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
time frame: Week 56
description: 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.
measure: Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: Change of Blood Eosinophil Levels' Measurement in Overall Patients
time frame: Week 56
description: Change from baseline to Week 56 in Blood eosinophils
measure: Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
time frame: Week 108
description: Change from baseline to Week 108 in Blood eosinophils.
measure: Change From Baseline in EQ-5D-5L Visual Analog Scale
time frame: Week 56
description: 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.
measure: Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
time frame: Week 68
description: 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.
measure: Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
time frame: Week 56
description: 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.
measure: Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
time frame: Week 68
description: 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.
measure: Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
time frame: Week 108
description: 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.
measure: 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
time frame: From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
description: Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
measure: 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)
time frame: Baseline and Week 108
description: Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
measure: Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
time frame: Week 0 and Week 56
description: Endpoint: Pharmacokinetic (PK) parameters
measure: Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
time frame: Baseline and Week 108
description: Endpoint: Pharmacokinetic (PK) parameters
measure: Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
time frame: 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
description: Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
measure: Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
time frame: 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
description: Assessments for the presence of ADA and nAb throughout study
arm group label: Benralizumab Arm A
arm group type: Experimental
description: Benralizumab administered subcutaneously
arm group label: Benralizumab Arm B
arm group type: Experimental
description: Benralizumab administered subcutaneously
intervention type: Biological
intervention name: Benralizumab
description: Benralizumab administered subcutaneously
arm group label: Benralizumab Arm A
intervention type: Biological
intervention name: Benralizumab
description: Benralizumab administered subcutaneously
arm group label: Benralizumab Arm B
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
last name: William W. Busse, M.D., Professor of Medicine
role: Principal Investigator
affiliation: Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
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country: Argentina
country: Australia
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: France
country: Germany
country: Japan
country: Korea, Republic of
country: Peru
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Sweden
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Vietnam
country: Czech Republic
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=D3250C00021_Revised_CSP_3_16Dec2016_Redacted.pdf
description: Related Info
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=D3250C00021_SAP_Edition_3_11_Dec2017_Redacted.pdf
description: Related Info
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=BORA_clinical_study_protocol-redacted.pdf
description: BORA clinical study protocol-redacted
responsible party type: Sponsor
mesh term: Asthma
mesh term: Benralizumab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 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.
point of contact: 