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This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab Arm | Experimental | Subjects will receive 100 mg of Mepolizumab (in polypropylene syringe) injected subcutaneously (SC) once every 4 weeks for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Biological | Mepolizumab (a fully humanised IgG antibody) 100 mg injected SC once every 4 weeks for 12 months. Mepolizumab will be provided as a lyophilised cake in sterile vials |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions | AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. | From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points | Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90808 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34098955 | Derived | Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. | |
| 31507641 | Derived | Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115661 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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651 participants who completed the study MEA115588 or MEA115575 were enrolled in this study. Participants meeting all the inclusion criteria and none of the exclusion criteria received their first mepolizumab dose at Visit 1 and continued to receive mepolizumab subcutaneous (SC) injections approximately every 4 weeks for 12 months.
This study was an extension of MEA115588 (NCT01691521) and MEA115575 (NCT01691508). Participants who completed the prior studies were offered to enroll in this study. Assessments that were captured as part of exit visit for MEA115588 and MEA115575 served as Baseline visit for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepolizumab 100 mg SC | Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Annualized Rate of Exacerbations Per Year | Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. | Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose |
| Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score | The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. | From Baseline and up to Week 52 |
| Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study | AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants Hospitalized Due to Exacerbations and Adverse Events | AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions | Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS). | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52 | Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. | Baseline and Week 52 |
| Change From Baseline in Pulse Rate Assessed at Week 52 | Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. | Baseline and Week 52 |
| Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline | Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline | Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
| Newport Beach |
| California |
| 92663 |
| United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
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| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
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| GSK Investigational Site | Pittsburgh | Pennsylvania | PA 15213 | United States |
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| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| GSK Investigational Site | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
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| GSK Investigational Site | Rosario | Santa Fe Province | S2000DBS | Argentina |
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| GSK Investigational Site | New Lambton | New South Wales | 2310 | Australia |
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| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
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| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
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| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
| GSK Investigational Site | Berlin | 10367 | Germany |
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| GSK Investigational Site | Foggia | Apulia | 71100 | Italy |
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| GSK Investigational Site | Parma | Emilia-Romagna | 43100 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Pietra Ligure (SV) | Liguria | 17027 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | Perugia | Umbria | 06156 | Italy |
| GSK Investigational Site | Cittadella (PD) | Veneto | 35013 | Italy |
| GSK Investigational Site | Chiba | 296-8602 | Japan |
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| GSK Investigational Site | Guadalajara | Jalisco | 44100 | Mexico |
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| GSK Investigational Site | Daegu | 705-717 | South Korea |
| GSK Investigational Site | Donggu Gwangju | 501757 | South Korea |
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| GSK Investigational Site | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| GSK Investigational Site | Bradford | BD9 6RJ | United Kingdom |
| GSK Investigational Site | Liverpool | L9 7AL | United Kingdom |
| GSK Investigational Site | London | EC1M 6BQ | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| 31447130 | Derived | Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22. |
| 30954640 | Derived | Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available. |
| 27553751 | Derived | Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115661 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepolizumab 100 mg SC | Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Race/Ethnicity, Customized | Number | 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 | Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions | AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. | As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab. | Posted | Number | Participants | From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points | Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results. | AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles). | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Annualized Rate of Exacerbations Per Year | Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable. | AT Population | Posted | Mean | 95% Confidence Interval | Exacerbations per year | Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose |
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| Secondary | Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score | The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Score on scale | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Milliliters (mL) | From Baseline and up to Week 52 |
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| Secondary | Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study | AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. | AT Population. | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants Hospitalized Due to Exacerbations and Adverse Events | AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. | AT Population | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions | Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. | AT Population | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
|
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| Secondary | Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS). | AT Population, only participants with ECG results post-baseline were analyzed | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
|
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| Secondary | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose) | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Milliseconds (msec) | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline | 12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Number | participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52 | Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and Week 52 |
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| Secondary | Change From Baseline in Pulse Rate Assessed at Week 52 | Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. | AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Posted | Mean | Standard Deviation | Beats per minute (BPM) | Baseline and Week 52 |
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| Secondary | Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline | Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. | AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles). | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
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| Secondary | Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline | Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. | AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles). | Posted | Number | Participants | From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose]) |
|
Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab up to 52 weeks.
Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
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 | Mepolizumab 100 mg SC | Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. | 94 | 651 | 461 | 651 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyskinesia oesophageal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
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| Hypertensive heart disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA | Systematic Assessment |
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| Type IV hypersensitivity reaction | Immune system disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nephrocalcinosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C434107 | mepolizumab |
Not provided
Not provided
Not provided
| Asian - Central/South Asian Heritage |
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| Asian - East Asian Heritage |
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| Asian - Japanese Heritage |
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| Asian - South East Asian Heritage |
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| Native Hawaiian or Other Pacific Islander |
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| White - Arabic/North African Heritage |
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| White - White/Caucasian/European Heritage |
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| Mixed Race |
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