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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001040-35 | EudraCT Number |
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The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.
This is a Phase IIIb, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and the safety of repeat dosing of benralizumab 30 mg subcutaneous (sc) versus placebo on top of standard of care asthma therapy in patients with severe uncontrolled asthma. Approximately 630 patients with peripheral blood eosinophil counts ≥150 cells/μL will be randomized 2:1 to receive benralizumab 30 mg sc or matched placebo for 24 weeks.
After enrolment, eligible patients will enter an up to 42-day screening/run-in period. Patients who meet eligibility criteria will be randomized 2:1 on Day 0 to receive either benralizumab or placebo every 56 days (every 8 weeks) through Week 16, with end of treatment (EOT) at Day 168 (Week 24). At the completion of the 24-week doubleblind period of the ANDHI study, eligible patients in benralizumab and placebo arm may enter a 56-week open label period (ANDHI in Practice [ANDHI IP] substudy), in which concomitant asthma therapies will be tapered as directed by the protocol in those patients who achieve and maintain asthma control (defined as ACQ6 score <1.5 and no clinically significant asthma exacerbations that required a burst of systemic corticosteroid or a hospitalization due to asthma between reduction visits) with add-on benralizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab (Medi-563) | Experimental | Benralizumab (Medi563) Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72). |
|
| Placebo | Placebo Comparator | Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab (Medi-563) | Drug | 30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72). |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) | An asthma exacerbation was defined as a worsening of asthma that led to any of the following:
Annual exacerbation rate = 365.25*total number of exacerbations / total duration of follow-up within the treatment group. Annual asthma exacerbation rates over the 24-week period were estimated using a negative binomial model. | Baseline (Week 0) up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Total Score to the EOT (Week 24) | The SGRQ is a 50-item patient-reported outcome instrument which measures the health status of patients with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ total score indicates the impact of disease on overall health status and is expressed as a percentage of overall impairment (scores range from 0 to100, with 100 representing worst possible health status and 0 indicating the best possible health status). The least squares (LS) mean change from baseline in SGRQ total score at Week 24 is presented. |
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Inclusion Criteria:
Female and male patients aged 18 to 75 years inclusively at the time of Visit 1 with a history of physician-diagnosed asthma requiring treatment with medium-to-high dose Inhaled Corticosteroids (ICS) plus asthma controller, for at least 12 months prior to Visit 1.
Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to Visit 1.
History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1.
ACQ6 score ≥1.5 at Visit 1.
Screening pre-bronchodilator (pre-BD) FEV1 of <80% predicted at Visit 2.
Excessive variability in lung function by satisfying ≥ 1 of the following criteria:
Peripheral blood eosinophil count either:
OR
≥150 to <300 cells/μL assessed by central laboratory at either Visit 1 or Visit 2, IF ≥1 of the following 5 clinical criteria (a to e) is met:
For inclusion in the open label ANDHI IP sub study patients should meet the following criteria:
Exclusion Criteria:
Exclusion criteria for the open label ANDHI IP sub study:
Patients should not enter the open label ANDHI IP sub study if any of the following exclusion criteria are fulfilled. Each exclusion criterion should be reviewed in all potential participants, including those who transition directly from the double-blind period and those with a delay between completing the EOT Visit 11 and the first open label visit (Visit 13).
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| Name | Affiliation | Role |
|---|---|---|
| Brad Goodman, MD | Aero Allergy Research Lab of Savannah | Principal Investigator |
| Vinay Sikand, MD | Sikand Institute of Pulmonary Research | Principal Investigator |
| Willaim Cherry, MD | Riverside Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36948488 | Derived | Louis R, Harrison TW, Chanez P, Menzella F, Philteos G, Cosio BG, Lugogo NL, de Luiz G, Burden A, Adlington T, Keeling N, Kwiatek J, Garcia Gil E; ANDHI Study Investigators. Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1759-1770.e7. doi: 10.1016/j.jaip.2023.03.009. Epub 2023 Mar 21. | |
| 33710614 |
| Label | URL |
|---|---|
| CSP redacted | View source |
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Severe eosinophilic patients were to have had ≥ 2 asthma exacerbations while on maintenance inhaled corticosteroids (ICS) plus another asthma controller that required treatment with systemic corticosteroids in the 12 months prior to enrolment. Patients continued to receive their standard of care asthma therapy throughout the study period.
Patients with severe uncontrolled asthma and peripheral blood eosinophil counts of ≥150 cells/microliter (μL) (with major subgroups of 150-300 cells/μL plus clinical features and ≥300 cells/μL) were recruited to 221 centers in 14 countries. Patients were randomized in a 2:1 ratio to receive benralizumab or matched placebo for 24 weeks. Results are reported for the double-blind period of the study (data cut-off: 12 Sep 2019).
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| ID | Title | Description |
|---|---|---|
| FG000 | Benralizumab | Patients received benralizumab 30 milligrams (mg) administered subcutaneously (sc) in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An End of Treatment (EOT) visit was performed at Week 24. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2020 | Sep 24, 2020 |
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| Placebo | Drug | Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) |
|
| Baseline (Week 0) and Week 24 |
| Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in First Second (FEV1) to the EOT (Week 24) | Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorized delegate according to American Thoracic Society/European Respiratory Society guidelines. The LS mean change from baseline in pre-BD FEV1 at Week 24 is presented. | Baseline (Week 0) and Week 24 |
| Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score to the EOT (Week 24) | The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath and wheezing) and short-acting β-2 receptor agonist use. Patients were asked to recall the status of their asthma during the previous week and respond to the questions of the ACQ-6 on a 7-point scale. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is computed as the mean of the responses from all the items in the questionnaire. Mean scores of ≤0.75 indicated well-controlled asthma, scores between 0.75 and <1.5 indicated partly-controlled asthma, and a score ≥1.5 indicated not well-controlled asthma. The LS mean change from baseline in ACQ-6 score at Week 24 is presented. | Baseline (Week 0) and Week 24 |
| Time to First Asthma Exacerbation (up to Week 24) | Time to first asthma exacerbation was derived as follows: Start date of first asthma exacerbation - Date of randomization + 1. The time to first asthma exacerbation for patients who did not experience an asthma exacerbation during the treatment period was censored at the EOT visit (Week 24) for patients who completed the study. Patients who withdrew from the study or were lost to follow-up before the EOT visit were censored at the last visit date after which an exacerbation could not be assessed. The median time to first asthma exacerbation was not calculated, so the number of patients who experienced an asthma exacerbation is presented for the measured values. | Baseline (Week 0) up to Week 24 |
| Change From Run-in Baseline Home Peak Expiratory Flow (PEF) (Morning and Evening) to the EOT (Week 24) | Home PEF testing was performed by the patient each morning after awakening and before taking their morning asthma medications, and each evening using a peak flow meter. Measurements were taken at approximately the same time each day and recorded in the Asthma Daily Diary. The maximum of the 3 measurements performed every morning and evening were used in the calculation of the weekly means. A weekly mean was calculated as the sum of all non-missing daily measures over the 7 sequential days divided by the number of non-missing daily measures. If more than 3 daily measures (> 50%) within a period were missing, then the weekly mean for that period was set to 'missing'. Change from run-in baseline in weekly means for morning PEF and evening PEF are presented. Baseline was the average for data collected over the last 7 days of the run-in period prior to randomization. | Run-in baseline (from Day -28 to Day 0) and Week 24 |
| Change From Baseline in Short Form 36-item Health Survey, Version 2 (SF-36v2) to the EOT (Week 24) | The SF-36v2 is a 36-item survey of functional health and well-being, with a 1 week recall period. The 8-domain profile consists of the following subscales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The physical and mental health component summary scores are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. Each domain score, as well as the physical and mental component scores, were scored on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Norm-based scoring was used to calculate the 8 SF-36v2 subscales and the 2 component scores. The LS mean change from baseline in each of the SF-36 subscale and component summary scores at Week 24 are presented. | Baseline (Week 0) and Week 24 |
| Patient Global Impression of Severity (PGI-S): Responder Status at the EOT (Week 24) | The PGI-S is a single question asking the patient to rate the overall severity of their symptoms using a 6-point categorical response scale from 0 to 5 where 0=no symptoms and 5=very severe symptoms. Higher scores indicate a worse outcome. Improvement was defined as a PGI-S at EOT (Week 24) better than PGI-S at baseline. Important improvement was defined as PGI-S at baseline = moderate symptoms or severe symptoms or very severe symptoms shifting to PGI-S at EOT = no symptoms or very mild symptoms or mild symptoms. Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated PGI-S responder categories are presented. | Baseline (Week 0) and Week 24 |
| Clinician Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C): Responder Status at the EOT (Week 24) | The Investigator (clinician) and the patient were asked separately to rate the degree of change in the overall asthma status compared to the start of treatment, i.e. baseline randomization visit. A 7-point rating scale was used for the CGI-C (rated by Investigator) and PGI-C (rated by patient) where: 1=Very Much Improved; 2=Much Improved; 3=Minimally Improved; 4=No Changes; 5=Minimally Worse; 6=Much Worse, and 7=Very Much Worse. Higher scores indicate a worse outcome. Responder category definitions: Much improved = (Much improved, Very much improved); Very much improved = (Very much improved). Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated CGI-C and PGI-C responder categories are presented. | Baseline (Week 0) and Week 24 |
| Change From Baseline in Predominant Symptom and Impairment Assessment (PSIA) Severity Score for Average of Top 3 Ranked Symptoms/Impairments and for Top Ranked Symptom/Impairment at the EOT (Week 24) | For part 1 of the PSIA only administered at baseline, patients reviewed 8 concepts (including cardinal asthma symptoms, activities, awakenings, triggers) and selected those which were typically bothersome. Based on part 1 selections, part 2 of the PSIA produced a rank ordered list of bothersome concepts individualized per the patient for subsequent evaluation. For part 3 of the PSIA assessed at baseline and during the study, patients recorded the severity of each selected symptom or impairment using an 11-point numeric rating scale where: 0=Did not experience and 10=Worst I can imagine. Higher scores indicate a worse outcome. The LS mean change from baseline in PSIA severity score for the indicated categories at Week 24 are presented. A negative change from baseline indicates an improvement in symptoms. Note: Average PSIA was calculated only where all of top 3 ranked symptoms/impairments were available, otherwise average was set to missing. | Baseline (Week 0) and Week 24 |
| Change From Baseline in the Sino-Nasal Outcome Test Item 22 (SNOT-22) Total Score to the EOT (Week 24) | The 22-item SNOT 22 questionnaire was used to assess the rhinosinusitis health status and quality of life of patients with baseline chronic rhinosinusitis with nasal polyposis. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110. Higher scores indicate poorer outcomes. The LS mean changes from baseline in SNOT-22 total score in patients in the chronic rhinosinusitis with nasal polyposis sub-study analysis set at Week 24 are presented. | Baseline (Week 0) and Week 24 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Research Site | Little Rock | Arkansas | 72209 | United States |
| Research Site | Bakersfield | California | 93301 | United States |
| Research Site | Encinitas | California | 92024 | United States |
| Research Site | Long Beach | California | 90806 | United States |
| Research Site | Los Angeles | California | 90025 | United States |
| Research Site | Mission Viejo | California | 92691 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Riverside | California | 92506 | United States |
| Research Site | San Diego | California | 92108 | United States |
| Research Site | Stockton | California | 95207 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | New Haven | Connecticut | 06519 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Clearwater | Florida | 33765 | United States |
| Research Site | Jacksonville | Florida | 32099 | United States |
| Research Site | Kissimmee | Florida | 34741 | United States |
| Research Site | Miami | Florida | 33126 | United States |
| Research Site | Miami | Florida | 33173 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Albany | Georgia | 31707 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Peoria | Illinois | 61602 | United States |
| Research Site | South Bend | Indiana | 46617 | United States |
| Research Site | Iowa City | Iowa | 52242 | United States |
| Research Site | West Des Moines | Iowa | 50266 | United States |
| Research Site | Lakeside Park | Kentucky | 41017 | United States |
| Research Site | Owensboro | Kentucky | 42301 | United States |
| Research Site | Shreveport | Louisiana | 71106 | United States |
| Research Site | Chevy Chase | Maryland | 20815 | United States |
| Research Site | White Marsh | Maryland | 21162 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Ypsilanti | Michigan | 48197 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | St Louis | Missouri | 63156 | United States |
| Research Site | Missoula | Montana | 59808 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | Highland Park | New Jersey | 08904 | United States |
| Research Site | Marlton | New Jersey | 08053 | United States |
| Research Site | Northfield | New Jersey | 08225 | United States |
| Research Site | Piscataway | New Jersey | 08854 | United States |
| Research Site | Toms River | New Jersey | 08755 | United States |
| Research Site | Verona | New Jersey | 07044 | United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | New Hyde Park | New York | 11042 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Rochester | New York | 14618 | United States |
| Research Site | Staten Island | New York | 10305 | United States |
| Research Site | Staten Island | New York | 10310 | United States |
| Research Site | The Bronx | New York | 10459 | United States |
| Research Site | Charlotte | North Carolina | 28277 | United States |
| Research Site | Elizabeth City | North Carolina | 27909 | United States |
| Research Site | Gastonia | North Carolina | 28054 | United States |
| Research Site | Greenville | North Carolina | 27834 | United States |
| Research Site | High Point | North Carolina | 27262 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Cincinnati | Ohio | 45231 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Grove City | Ohio | 43123 | United States |
| Research Site | Edmond | Oklahoma | 73034 | United States |
| Research Site | Tulsa | Oklahoma | 74136 | United States |
| Research Site | Clackamas | Oregon | 97015-5737 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Site | Reading | Pennsylvania | 19610 | United States |
| Research Site | Anderson | South Carolina | 29621 | United States |
| Research Site | Gaffney | South Carolina | 29340 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Greenville | South Carolina | 29615 | United States |
| Research Site | North Charleston | South Carolina | 29420-4211 | United States |
| Research Site | Rock Hill | South Carolina | 29732 | United States |
| Research Site | Sioux Falls | South Dakota | 57108 | United States |
| Research Site | Franklin | Tennessee | 37067 | United States |
| Research Site | Cypress | Texas | 77429 | United States |
| Research Site | Dallas | Texas | 75225 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Fort Worth | Texas | 76109 | United States |
| Research Site | Galveston | Texas | 77555 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78249 | United States |
| Research Site | San Antonio | Texas | 78251 | United States |
| Research Site | Provo | Utah | 84604 | United States |
| Research Site | South Burlington | Vermont | 05403 | United States |
| Research Site | Abingdon | Virginia | 24210 | United States |
| Research Site | Fairfax | Virginia | 22030 | United States |
| Research Site | North Chesterfield | Virginia | 23225 | United States |
| Research Site | Williamsburg | Virginia | 23188 | United States |
| Research Site | Everett | Washington | 98208 | United States |
| Research Site | Spokane | Washington | 99204 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Milwaukee | Wisconsin | 53228 | United States |
| Research Site | West Allis | Wisconsin | 53227 | United States |
| Research Site | Feldbach | A-8330 | Austria |
| Research Site | Vienna | 1130 | Austria |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Montigny-le-Tilleul | 6110 | Belgium |
| Research Site | Namur | 5101 | Belgium |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Kelowna | British Columbia | V1W 1V3 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Research Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Mississauga | Ontario | L5A 3V4 | Canada |
| Research Site | Toronto | Ontario | M5T 3A9 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Aarhus N | 8200 | Denmark |
| Research Site | Odense C | 5000 | Denmark |
| Research Site | Vejle | 7100 | Denmark |
| Research Site | Helsinki | 00290 | Finland |
| Research Site | Turku | 20520 | Finland |
| Research Site | Bayonne | 64100 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Dijon | 21079 | France |
| Research Site | Grenoble | 38043 | France |
| Research Site | La Roche-sur-Yon | 85925 | France |
| Research Site | Le Kremlin-Bicêtre | 94270 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Lyon | 69317 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Montpellier | 34090 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Nice | 06002 | France |
| Research Site | Paris | 75877 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Reims | 51092 | France |
| Research Site | Rouen | 76031 | France |
| Research Site | Saint-Quentin | 02321 | France |
| Research Site | Strasbourg | 67091 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Vandœuvre-lès-Nancy | 54511 | France |
| Research Site | Berlin | 14059 | Germany |
| Research Site | Bochum | 44789 | Germany |
| Research Site | Bonn | 53105 | Germany |
| Research Site | Cottbus | 03050 | Germany |
| Research Site | Essen | 45239 | Germany |
| Research Site | Hamburg | 20354 | Germany |
| Research Site | Jena | 07747 | Germany |
| Research Site | Marburg | 30625 | Germany |
| Research Site | Oldenburg | 23758 | Germany |
| Research Site | Regensburg | 93053 | Germany |
| Research Site | Rheine | 48431 | Germany |
| Research Site | Rüdersdorf | 15562 | Germany |
| Research Site | Wangen | 88239 | Germany |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Catania | 95123 | Italy |
| Research Site | Catanzaro | 88100 | Italy |
| Research Site | Cona | 44124 | Italy |
| Research Site | Foggia | 71100 | Italy |
| Research Site | Garbagnate Milanese | 20024 | Italy |
| Research Site | Legnago | 37045 | Italy |
| Research Site | Matera | Italy |
| Research Site | Milan | 20157 | Italy |
| Research Site | Milan | 20122 | Italy |
| Research Site | Modena | 41124 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Palermo | 90127 | Italy |
| Research Site | Pavia | 27100 | Italy |
| Research Site | Piacenza | 29100 | Italy |
| Research Site | Pietra Ligure | 17027 | Italy |
| Research Site | Reggio Emilia | 42123 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Verona | 37126 | Italy |
| Research Site | Amersfoort | 3813 TZ | Netherlands |
| Research Site | Deventer | 7416 SE | Netherlands |
| Research Site | Enschede | 7513 ER | Netherlands |
| Research Site | Harderwijk | 3844 DG | Netherlands |
| Research Site | Helmond | 5707 HA | Netherlands |
| Research Site | Nijmegen | 6532 SZ | Netherlands |
| Research Site | Zwolle | 8025 AB | Netherlands |
| Research Site | Bergen | 5021 | Norway |
| Research Site | Lørenskog | N-1478 | Norway |
| Research Site | Badalona(Barcelona) | 08916 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Benalmádena | 29631 | Spain |
| Research Site | Jerez de la Frontera | 11407 | Spain |
| Research Site | Laredo | 39770 | Spain |
| Research Site | Madrid | 28031 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Málaga | 29730 | Spain |
| Research Site | Palma de Mallorca | 07010 | Spain |
| Research Site | Pozuelo de Alarcón | 28223 | Spain |
| Research Site | Sabadell | 08208 | Spain |
| Research Site | Salamanca | 37007 | Spain |
| Research Site | Santiago de Compostela | 15706 | Spain |
| Research Site | Seville | 41009 | Spain |
| Research Site | Taco | 38108 | Spain |
| Research Site | Valdemoro | 28342 | Spain |
| Research Site | Lund | 221 85 | Sweden |
| Research Site | Östersund | 831 83 | Sweden |
| Research Site | Stockholm | SE-181 58 | Sweden |
| Research Site | Birmingham | B9 5SS | United Kingdom |
| Research Site | Bradford | BND9 6RJ | United Kingdom |
| Research Site | Cambridge | CB2 2QQ | United Kingdom |
| Research Site | Chertsey | KT16 0PZ | United Kingdom |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | Glasgow | G51 4TF | United Kingdom |
| Research Site | London | EC1A 7BE | United Kingdom |
| Research Site | Nottingham | NG5 1PB | United Kingdom |
| Derived |
| Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3. |
| 33357499 | Derived | Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG, Lugogo NL, Mohan A, Burden A, McDermott L, Garcia Gil E, Zangrilli JG; ANDHI study investigators. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respir Med. 2021 Mar;9(3):260-274. doi: 10.1016/S2213-2600(20)30414-8. Epub 2020 Dec 22. |
| SAP redacted | View source |
| CSR Synopsis | View source |
Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
| Received Treatment |
|
| COMPLETED | Completed double-blind period of study |
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| NOT COMPLETED |
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All patients in the full analysis set (FAS) who received any investigational product (IP) were included in the baseline analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benralizumab | Patients received benralizumab 30 mg administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
| BG001 | Placebo | Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Screening eosinophil count group (cells/µL) | Count of Participants | Participants |
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| Baseline eosinophil count group (cells/μL) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) | An asthma exacerbation was defined as a worsening of asthma that led to any of the following:
Annual exacerbation rate = 365.25*total number of exacerbations / total duration of follow-up within the treatment group. Annual asthma exacerbation rates over the 24-week period were estimated using a negative binomial model. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | 95% Confidence Interval | Events/year | Baseline (Week 0) up to Week 24 |
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| Secondary | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Total Score to the EOT (Week 24) | The SGRQ is a 50-item patient-reported outcome instrument which measures the health status of patients with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ total score indicates the impact of disease on overall health status and is expressed as a percentage of overall impairment (scores range from 0 to100, with 100 representing worst possible health status and 0 indicating the best possible health status). The least squares (LS) mean change from baseline in SGRQ total score at Week 24 is presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Week 0) and Week 24 |
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| Secondary | Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in First Second (FEV1) to the EOT (Week 24) | Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorized delegate according to American Thoracic Society/European Respiratory Society guidelines. The LS mean change from baseline in pre-BD FEV1 at Week 24 is presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters (L) | Baseline (Week 0) and Week 24 |
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| Secondary | Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score to the EOT (Week 24) | The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath and wheezing) and short-acting β-2 receptor agonist use. Patients were asked to recall the status of their asthma during the previous week and respond to the questions of the ACQ-6 on a 7-point scale. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is computed as the mean of the responses from all the items in the questionnaire. Mean scores of ≤0.75 indicated well-controlled asthma, scores between 0.75 and <1.5 indicated partly-controlled asthma, and a score ≥1.5 indicated not well-controlled asthma. The LS mean change from baseline in ACQ-6 score at Week 24 is presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Week 0) and Week 24 |
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| Secondary | Time to First Asthma Exacerbation (up to Week 24) | Time to first asthma exacerbation was derived as follows: Start date of first asthma exacerbation - Date of randomization + 1. The time to first asthma exacerbation for patients who did not experience an asthma exacerbation during the treatment period was censored at the EOT visit (Week 24) for patients who completed the study. Patients who withdrew from the study or were lost to follow-up before the EOT visit were censored at the last visit date after which an exacerbation could not be assessed. The median time to first asthma exacerbation was not calculated, so the number of patients who experienced an asthma exacerbation is presented for the measured values. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Count of Participants | Participants | Baseline (Week 0) up to Week 24 |
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| Secondary | Change From Run-in Baseline Home Peak Expiratory Flow (PEF) (Morning and Evening) to the EOT (Week 24) | Home PEF testing was performed by the patient each morning after awakening and before taking their morning asthma medications, and each evening using a peak flow meter. Measurements were taken at approximately the same time each day and recorded in the Asthma Daily Diary. The maximum of the 3 measurements performed every morning and evening were used in the calculation of the weekly means. A weekly mean was calculated as the sum of all non-missing daily measures over the 7 sequential days divided by the number of non-missing daily measures. If more than 3 daily measures (> 50%) within a period were missing, then the weekly mean for that period was set to 'missing'. Change from run-in baseline in weekly means for morning PEF and evening PEF are presented. Baseline was the average for data collected over the last 7 days of the run-in period prior to randomization. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | L/minute | Run-in baseline (from Day -28 to Day 0) and Week 24 |
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| Secondary | Change From Baseline in Short Form 36-item Health Survey, Version 2 (SF-36v2) to the EOT (Week 24) | The SF-36v2 is a 36-item survey of functional health and well-being, with a 1 week recall period. The 8-domain profile consists of the following subscales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The physical and mental health component summary scores are computed from subscale scores to give a broader metric of physical and mental health-related quality of life. Each domain score, as well as the physical and mental component scores, were scored on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Norm-based scoring was used to calculate the 8 SF-36v2 subscales and the 2 component scores. The LS mean change from baseline in each of the SF-36 subscale and component summary scores at Week 24 are presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Week 0) and Week 24 |
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| Secondary | Patient Global Impression of Severity (PGI-S): Responder Status at the EOT (Week 24) | The PGI-S is a single question asking the patient to rate the overall severity of their symptoms using a 6-point categorical response scale from 0 to 5 where 0=no symptoms and 5=very severe symptoms. Higher scores indicate a worse outcome. Improvement was defined as a PGI-S at EOT (Week 24) better than PGI-S at baseline. Important improvement was defined as PGI-S at baseline = moderate symptoms or severe symptoms or very severe symptoms shifting to PGI-S at EOT = no symptoms or very mild symptoms or mild symptoms. Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated PGI-S responder categories are presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Percentage of patients | Baseline (Week 0) and Week 24 |
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| Secondary | Clinician Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C): Responder Status at the EOT (Week 24) | The Investigator (clinician) and the patient were asked separately to rate the degree of change in the overall asthma status compared to the start of treatment, i.e. baseline randomization visit. A 7-point rating scale was used for the CGI-C (rated by Investigator) and PGI-C (rated by patient) where: 1=Very Much Improved; 2=Much Improved; 3=Minimally Improved; 4=No Changes; 5=Minimally Worse; 6=Much Worse, and 7=Very Much Worse. Higher scores indicate a worse outcome. Responder category definitions: Much improved = (Much improved, Very much improved); Very much improved = (Very much improved). Patients with missing data at the EOT visit who did not complete the study were considered non-responders. For patients who completed the study with missing data at EOT (Week 24), their last evaluable post-baseline score was used to define responder status. The percentage of patients for each of the indicated CGI-C and PGI-C responder categories are presented. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Percentage of patients | Baseline (Week 0) and Week 24 |
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| Secondary | Change From Baseline in Predominant Symptom and Impairment Assessment (PSIA) Severity Score for Average of Top 3 Ranked Symptoms/Impairments and for Top Ranked Symptom/Impairment at the EOT (Week 24) | For part 1 of the PSIA only administered at baseline, patients reviewed 8 concepts (including cardinal asthma symptoms, activities, awakenings, triggers) and selected those which were typically bothersome. Based on part 1 selections, part 2 of the PSIA produced a rank ordered list of bothersome concepts individualized per the patient for subsequent evaluation. For part 3 of the PSIA assessed at baseline and during the study, patients recorded the severity of each selected symptom or impairment using an 11-point numeric rating scale where: 0=Did not experience and 10=Worst I can imagine. Higher scores indicate a worse outcome. The LS mean change from baseline in PSIA severity score for the indicated categories at Week 24 are presented. A negative change from baseline indicates an improvement in symptoms. Note: Average PSIA was calculated only where all of top 3 ranked symptoms/impairments were available, otherwise average was set to missing. | The FAS included all randomized patients who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Week 0) and Week 24 |
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| Secondary | Change From Baseline in the Sino-Nasal Outcome Test Item 22 (SNOT-22) Total Score to the EOT (Week 24) | The 22-item SNOT 22 questionnaire was used to assess the rhinosinusitis health status and quality of life of patients with baseline chronic rhinosinusitis with nasal polyposis. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110. Higher scores indicate poorer outcomes. The LS mean changes from baseline in SNOT-22 total score in patients in the chronic rhinosinusitis with nasal polyposis sub-study analysis set at Week 24 are presented. | The chronic rhinosinusitis with nasal polyposis sub-study analysis set was defined as the subset of patients with doctor-diagnosed chronic rhinosinusitis and nasal polyposis included in their medical history who had signed the informed consent to participate in the sub-study and who had received at least 1 dose of IP. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Week 0) and Week 24 |
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Adverse event (AE) data is reported for the on-treatment period + follow-up (up to a maximum of 24 weeks). Assessed until 12 Sep 2019 analysis cut-off date.
AE definition for on-treatment period: onset date ≥ first dose of IP and ≤ scheduled EOT visit, or IP discontinuation (IPD) visit for patients prematurely discontinuing IP. If both EOT and IPD visits were missing, upper limit of the on-treatment period was defined as day of last dose of IP + 56 days. If upper limit was after end of the on-study period, upper limit was set to end of on-study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benralizumab | Patients received benralizumab 30 mg administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. | 0 | 427 | 23 | 427 | 136 | 427 |
| EG001 | Placebo | Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. | 0 | 229 | 25 | 229 | 78 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Mydriasis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
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| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Oct 20, 2021 | SAP_002.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| D007249 | Inflammation |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C571386 | benralizumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Missing |
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| ≥ 300 |
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| Missing |
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| ≥ 300 - < 450 |
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| ≥ 450 |
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Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
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| Units |
|---|
| Counts |
|---|
| Participants |
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Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24.
|
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|
|
|
|
| Placebo |
Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
|
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| OG001 |
| Placebo |
Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
|
|
|
|
|
|
| Placebo |
Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
|
|
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| OG001 | Placebo | Patients received matching placebo solution administered sc in an accessorized pre-filled syringe at Week 0 (initial dose), Week 4 (loading dose), Week 8 and Week 16. An EOT visit was performed at Week 24. |
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