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The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.
A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53. |
|
| MEDI8968 600 mg IV, 300 mg SC | Experimental | MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI8968 600 mg IV, 300 mg SC | Biological | MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year. | Day 1 up to 393 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene Van Der Merwe, MBChB, MFPM | MedImmune Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Peoria | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28793896 | Derived | Calverley PMA, Sethi S, Dawson M, Ward CK, Finch DK, Penney M, Newbold P, van der Merwe R. A randomised, placebo-controlled trial of anti-interleukin-1 receptor 1 monoclonal antibody MEDI8968 in chronic obstructive pulmonary disease. Respir Res. 2017 Aug 9;18(1):153. doi: 10.1186/s12931-017-0633-7. |
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A total of 464 participants were screened and 324 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53. |
| FG001 | MEDI8968 600 mg IV, 300 mg SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53. |
|
| Day 1 up to 393 |
| Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. | Day 1 up to 393 |
| Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53 | The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. | Baseline and Week 53 |
| Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score | The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively. | Week 53 |
| Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53 | The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). | Baseline and Week 53 |
| Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score | The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported. | Baseline and Week 53 |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs. | Day 1 up to Week 69 |
| Observed Serum Concentrations of MEDI8968 | Pre-dose (Baseline), Post-dose on Week 53 |
| Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit | Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis. | Day 1 up to Week 69 |
| Clearwater |
| Florida |
| United States |
| Research Site | Duluth | Georgia | United States |
| Research Site | Auburn | Maine | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | Boerne | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Stara Zagora | Bulgaria |
| Research Site | Veliko Tarnovo | Bulgaria |
| Research Site | Brno | Czechia |
| Research Site | Jindřichův Hradec | Czechia |
| Research Site | Karlovy Vary | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Strakonice | Czechia |
| Research Site | Balassagyarmat | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Farkasgyepü | Hungary |
| Research Site | Komárom | Hungary |
| Research Site | Mátészalka | Hungary |
| Research Site | Mátraháza | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Nagykanizsa | Hungary |
| Research Site | Szikszó | Hungary |
| Research Site | Tatabánya | Hungary |
| Research Site | Törökbálint | Hungary |
| Research Site | Daugavpils | Latvia |
| Research Site | Riga | Latvia |
| Research Site | Kaunas | Lithuania |
| Research Site | Klaipėda | Lithuania |
| Research Site | Vilnius | Lithuania |
| Research Site | Iloilo City | Philippines |
| Research Site | Lipa City | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Bialystok | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Oświęcim | Poland |
| Research Site | Poznan | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zgierz | Poland |
| Research Site | Ivano-Frankivsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Odesa | Ukraine |
| Research Site | Poltava | Ukraine |
| Research Site | Simferopol | Ukraine |
| Research Site | Vinnytsia | Ukraine |
| Research Site | Cambridge | United Kingdom |
| Research Site | Newcastle upon Tyne | United Kingdom |
| Research Site | Wolverhampton | United Kingdom |
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
| COMPLETED |
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| NOT COMPLETED |
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|
Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53. |
| BG001 | MEDI8968 600 mg IV, 300 mg SC | MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year. | Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product. | Posted | Mean | 90% Confidence Interval | AECOPD events/year | Day 1 up to 393 |
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| Secondary | Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year. | The mITT population included all participants who were randomized into the study and received any investigational product. | Posted | Mean | 90% Confidence Interval | AECOPD events/year | Day 1 up to 393 |
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| Secondary | Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. | The mITT population included all participants who were randomized into the study and received any investigational product. | Posted | Median | Inter-Quartile Range | days | Day 1 up to 393 |
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| Secondary | Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53 | The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. | The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Error | units on scale | Baseline and Week 53 |
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| Secondary | Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score | The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively. | The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | percentage of participants | Week 53 |
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| Secondary | Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53 | The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). | The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 53 |
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| Secondary | Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score | The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported. | The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure. | Posted | Number | percentage of participants | Baseline and Week 53 |
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| Secondary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs. | Safety population included all participants who were randomized and received at least one dose of investigational product. | Posted | Number | participants | Day 1 up to Week 69 |
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| Secondary | Observed Serum Concentrations of MEDI8968 | PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration. | Posted | Mean | Standard Deviation | nanogram per milliliters (ng/mL) | Pre-dose (Baseline), Post-dose on Week 53 |
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| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit | Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis. | Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing. | Posted | Number | participants | Day 1 up to Week 69 |
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Day 1 up to Week 69
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO | Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53. | 35 | 164 | 127 | 164 | ||
| EG001 | MEDI8968 300 mg | MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5. | 41 | 160 | 122 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adams-stokes syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ebstein's anomaly | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Atypical mycobacterial pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rene van der Merwe, MBChB/Senior Director, Clinical Development | MedImmune, LLC. | 301-398-0000 | vandermerwer@medimmune.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
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| Participants |
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| Participants |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n=145) |
| |||||
| Week 53 (n=120) |
|
|