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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002553-35 | EudraCT Number |
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This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:
Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 150 mg or QA039 450 mg or placebo was added to standard of care, GINA steps 4 and 5 asthma therapy.
The study included:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 150 mg | Experimental | QAW039 150 mg once daily |
|
| QAW039 450 mg | Experimental | QAW039 450 mg once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 | Drug | QAW039 150 mg once daily |
| |
| QAW039 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Baseline, Week 52 |
| Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32979986 | Derived | Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24. |
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The study included a Screening period of up to 2 weeks and a Placebo Run-in period of 2 to 6 weeks, during which eligibility for randomization was determined.
Participants were from Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Latvia, Lithuania, Philippines, Poland, Romania, Singapore, Spain, Switzerland, UK, US, Vietnam.
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| ID | Title | Description |
|---|---|---|
| FG000 | QAW039 150 mg | QAW039 150 mg once daily |
| FG001 | QAW039 450 mg | QAW039 450 mg once daily |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2019 | May 4, 2020 |
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| Drug |
QAW039 450 mg once daily |
|
| Placebo | Drug | Placebo once daily |
|
| 52 weeks |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Baseline, Week 52 |
| Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation | Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Baseline, Week 52 |
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population | The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. | Baseline, Week 52 |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). | Baseline, Week 52 |
| Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population | Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. | Baseline, Week 52 |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Novartis Investigative Site | Gilbert | Arizona | 85234 | United States |
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| Novartis Investigative Site | Porto Alegre | Porto Alegre RS | 90610 000 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
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| Novartis Investigative Site | Blumenau | Santa Catarina | 89030101 | Brazil |
| Novartis Investigative Site | Florianópolis | Santa Catarina | 88040-970 | Brazil |
| Novartis Investigative Site | São Bernardo do Campo | São Paulo | 09715 090 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04023-900 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403 000 | Brazil |
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| Novartis Investigative Site | Haikou | Hainan | 570311 | China |
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| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
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| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
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| Novartis Investigative Site | Helsinki | 00290 | Finland |
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| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Novartis Investigative Site | Berlin | 10717 | Germany |
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| Novartis Investigative Site | Berlin | 12627 | Germany |
| Novartis Investigative Site | Berlin | 13187 | Germany |
| Novartis Investigative Site | Frankfurt | 60313 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
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| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Landsberg | 86899 | Germany |
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| Novartis Investigative Site | Vilnius | LTU | LT-05263 | Lithuania |
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| Novartis Investigative Site | Zurich | 8032 | Switzerland |
| Novartis Investigative Site | Cambridge | Cambrigdeshire | CB2 0QQ | United Kingdom |
| Novartis Investigative Site | Darlington | Durham | DL3 6HX | United Kingdom |
| Novartis Investigative Site | London | GBR | EC1M 6BQ | United Kingdom |
| Novartis Investigative Site | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2WB | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
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| Novartis Investigative Site | Leicester | LE3 9QP | United Kingdom |
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| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Novartis Investigative Site | Ho Chi Minh City | 700000 | Vietnam |
| FG002 |
| Placebo |
Placebo once daily |
| FAS/SAF: High Eosinophil Subpopulation | Full analysis set/safety set. All patients who received study drug and had high eosinophils count |
|
| FAS/SAF: Overall Population | Full analysis set/safety set. All patients who received study drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QAW039 150 mg | QAW039 150 mg once daily |
| BG001 | QAW039 450 mg | QAW039 450 mg once daily |
| BG002 | Placebo | Placebo once daily |
| BG003 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Posted | Least Squares Mean | 95% Confidence Interval | events/year | Baseline, Week 52 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Posted | Least Squares Mean | Standard Error | units on scale | 52 weeks |
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| Secondary | Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Posted | Least Squares Mean | Standard Error | units on scale | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation | Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Posted | Least Squares Mean | Standard Error | Liter | Baseline, Week 52 |
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| Primary | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). | Full Analysis Set (FAS) in overall population | Posted | Least Squares Mean | 95% Confidence Interval | events/year | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population | The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. | Full Analysis Set (FAS) in overall population | Posted | Least Squares Mean | Standard Error | units on scale | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). | Full Analysis Set (FAS) overall population | Posted | Least Squares Mean | Standard Error | units on scale | Baseline, Week 52 |
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| Secondary | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population | Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. | Full Analysis Set (FAS) in overall population | Posted | Least Squares Mean | Standard Error | Liter | Baseline, Week 52 |
|
|
Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks.
Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
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 | QAW039 150 mg | QAW039 150 mg | 0 | 299 | 33 | 299 | 204 | 299 |
| EG001 | QAW039 450 mg | QAW039 450 mg | 1 | 293 | 30 | 293 | 193 | 293 |
| EG002 | Placebo | Placebo | 2 | 298 | 32 | 298 | 214 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia chlamydial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Thoracic spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Epithelioid mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Essential tremor | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Superior sagittal sinus thrombosis | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 10, 2017 | May 4, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| 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 |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604875 | fevipiprant |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Unknown |
|
| Other |
|
Adjusted p-values are based on the closed testing procedure |
| 0.510 |
adjusted p-value |
| Rate Ratio |
| 0.83 |
| 2-Sided |
| 95 |
| 0.61 |
| 1.14 |
| Superiority |
|
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| Participants |
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