Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 | Experimental | QVA149 (110/50 μg) once daily |
|
| Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS) | Active Comparator | Salmeterol/fluticasone (50/500μg) b.i.d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of COPD Exacerbations | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First COPD Exacerbation. | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ciudad de Buenos Aires | Argentina | C1425AUA | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41402044 | Derived | Mathioudakis AG, Bate S, Chatzimavridou-Grigoriadou V, Sivapalan P, Jensen JS, Bakerly ND, Vestbo J, Singh D. Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial. Thorax. 2026 May 14;81(6):533-540. doi: 10.1136/thorax-2025-223282. | |
| 38992490 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 | QVA149 (110/50 μg) once daily |
| FG001 | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | Salmeterol/fluticasone (50/500μg) twice a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Planned Treatment Epoch |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS) | Drug | Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device. |
|
| 52 weeks |
| Rate of Moderate to Severe COPD Exacerbations. | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. | 52 weeks |
| Time to First Moderate to Severe COPD Exacerbation. | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. | 52 weeks. |
| Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. | 52 weeks |
| Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included . | 52 weeks |
| Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. | All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization. | 52 weeks |
| Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included. | 52 weeks |
| Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | 52 weeks |
| Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | 52 weeks |
| Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | 52 weeks |
| Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | 52 weeks |
| Forced Expiratory Volume in 1 Second | Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, day 1 (30 min and one hour post dose) |
| Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, 4 weeks |
| Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, 12 weeks |
| Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, 26 weeks |
| Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, 38 weeks |
| Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | Baseline, 52 weeks |
| Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h) | Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time" | Baseline, 52 weeks |
| Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | Baseline, 4 weeks |
| Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | Baseline, 12 weeks |
| Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | Baseline, 26 weeks |
| Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | Baseline, 38 weeks |
| Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | Baseline, 52 weeks |
| Change From Baseline in the Number of Puffs of Rescue Medication | A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region. | Baseline, 52 weeks |
| Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol. | Urine cortisol/creatinine ratio | Baseline, 52 Weeks |
| Change From Baseline in Forced Vital Capacity | Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction | 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks |
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | The overall rate of adverse events reported from initiation through 30 days post last dose. | 52 weeks of treatment + 30 days |
| Buenos Aires |
| Buenos Aires |
| 1425 |
| Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1120AAC | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | 1122 | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1122AAK | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1414AIF | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1424BSF | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1425BEA | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1425BEN | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1426ABP | Argentina |
| Novartis Investigative Site | Lanus | Buenos Aires | B8000XAV | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | B7600 | Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires F.D. | C1028AAP | Argentina |
| Novartis Investigative Site | Concepción del Uruguay | Entre Ríos Province | 3260 | Argentina |
| Novartis Investigative Site | Mendoza | Mendoza Province | 5500 | Argentina |
| Novartis Investigative Site | Mendoza | Mendoza Province | M5500CBA | Argentina |
| Novartis Investigative Site | Salta | Salta Province | 4000 | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000AII | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000DBS | Argentina |
| Novartis Investigative Site | Santa Fe | Santa Fe Province | S3000FIL | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| Novartis Investigative Site | Feldbach | Austria | 8330 | Austria |
| Novartis Investigative Site | Feldkirch | Austria | 6800 | Austria |
| Novartis Investigative Site | Graz | Austria | A-8036 | Austria |
| Novartis Investigative Site | Grieskirchen | Austria | 4710 | Austria |
| Novartis Investigative Site | Linz | Austria | 4020 | Austria |
| Novartis Investigative Site | Thalheim bei Wels | Austria | 4600 | Austria |
| Novartis Investigative Site | Wels | Austria | 4600 | Austria |
| Novartis Investigative Site | Innsbruck | Tyrol | 6020 | Austria |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Vienna | A-1230 | Austria |
| Novartis Investigative Site | Gosselies | BEL | 6041 | Belgium |
| Novartis Investigative Site | Genk | Limburg | 3600 | Belgium |
| Novartis Investigative Site | Luxembourg | Luxembourg | 1210 | Belgium |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Brussels | 1090 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Erpent | 5101 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Gilly | 6060 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Ostend | 8400 | Belgium |
| Novartis Investigative Site | Roeselare | 8800 | Belgium |
| Novartis Investigative Site | Turnhout | 2300 | Belgium |
| Novartis Investigative Site | Wavre | 1301 | Belgium |
| Novartis Investigative Site | Rousse | Bulgaria | 7002 | Bulgaria |
| Novartis Investigative Site | Sofia | Bulgaria | 1431 | Bulgaria |
| Novartis Investigative Site | Varna | Bulgaria | 9020 | Bulgaria |
| Novartis Investigative Site | Gabrovo | 5300 | Bulgaria |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Troyan Municipality | 5600 | Bulgaria |
| Novartis Investigative Site | Calgary | Alberta | T2N 4n1 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Novartis Investigative Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| Novartis Investigative Site | Burlington | Ontario | L7N 3V2 | Canada |
| Novartis Investigative Site | Downsview | Ontario | M3N 2Z9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5T 3A9 | Canada |
| Novartis Investigative Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1M 1B1 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3G 1L5 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1N 4V3 | Canada |
| Novartis Investigative Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Novartis Investigative Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Novartis Investigative Site | Santiago | Santiago Metropolitan | Chile |
| Novartis Investigative Site | Quillota | 2260877 | Chile |
| Novartis Investigative Site | Santiago | 8910131 | Chile |
| Novartis Investigative Site | Beijing | Beijing Municipality | 100023 | China |
| Novartis Investigative Site | Beijing | Beijing Municipality | 100730 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510120 | China |
| Novartis Investigative Site | Haikou | Hainan | 570311 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 050000 | China |
| Novartis Investigative Site | Changsha | Hunan | 410003 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Suzhou | Jiangsu | 215006 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Shengyang | Liaoning | 110016 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200433 | China |
| Novartis Investigative Site | Xi’an | Shanxi | 710032 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310006 | China |
| Novartis Investigative Site | Beijing | 100050 | China |
| Novartis Investigative Site | Chongqing | 400037 | China |
| Novartis Investigative Site | Chongqing | 400038 | China |
| Novartis Investigative Site | Guangzhou | 510010 | China |
| Novartis Investigative Site | Shanghai | 200025 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| Novartis Investigative Site | Bogota | Cundinamarca | Colombia |
| Novartis Investigative Site | Floridablanca | Santander Department | 57-7 | Colombia |
| Novartis Investigative Site | Armenia | Colombia |
| Novartis Investigative Site | Medellín | Colombia |
| Novartis Investigative Site | Zagreb | Croatia | 10 000 | Croatia |
| Novartis Investigative Site | Karlovac | 47000 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Cvikov | Czech Republic | 471 54 | Czechia |
| Novartis Investigative Site | Český Krumlov | Czech Republic | 381 01 | Czechia |
| Novartis Investigative Site | Jindrichuv Hradec III | Czech Republic | 377 01 | Czechia |
| Novartis Investigative Site | Liberec | Czech Republic | 460 01 | Czechia |
| Novartis Investigative Site | Mělník | Czech Republic | 267 01 | Czechia |
| Novartis Investigative Site | Ostrava | Czech Republic | 708 68 | Czechia |
| Novartis Investigative Site | Ostrava - Hrabuvka | Czech Republic | 70030 | Czechia |
| Novartis Investigative Site | Pardubice | Czech Republic | 530 09 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 108 00 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 142 00 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 158 00 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 169 00 | Czechia |
| Novartis Investigative Site | Praha 6 - Repy | Czech Republic | 163 00 | Czechia |
| Novartis Investigative Site | Strakonice | Czech Republic | 38601 | Czechia |
| Novartis Investigative Site | Teplice | Czech Republic | 415 01 | Czechia |
| Novartis Investigative Site | Žatec | Czech Republic | 438 01 | Czechia |
| Novartis Investigative Site | Benešov | 256 30 | Czechia |
| Novartis Investigative Site | Olomouc | 775 20 | Czechia |
| Novartis Investigative Site | Aalborg | Denmark | DK-9000 | Denmark |
| Novartis Investigative Site | Hellerup | Denmark | DK-2900 | Denmark |
| Novartis Investigative Site | Hvidovre | Denmark | DK-2650 | Denmark |
| Novartis Investigative Site | Roskilde | Denmark | DK-4000 | Denmark |
| Novartis Investigative Site | Silkeborg | Denmark | 8600 | Denmark |
| Novartis Investigative Site | Sønderborg | Denmark | DK-6400 | Denmark |
| Novartis Investigative Site | Aarhus | DK-8000 | Denmark |
| Novartis Investigative Site | Copenhagen NV | DK-2400 | Denmark |
| Novartis Investigative Site | Næstved | 4700 | Denmark |
| Novartis Investigative Site | Tartu | Estonia | 51014 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tallinn | 13619 | Estonia |
| Novartis Investigative Site | Turku | Finland | FIN-20100 | Finland |
| Novartis Investigative Site | Helsinki | 00290 | Finland |
| Novartis Investigative Site | HUS | 00029 | Finland |
| Novartis Investigative Site | Jyväskylä | 40100 | Finland |
| Novartis Investigative Site | Kuopio | FIN-70211 | Finland |
| Novartis Investigative Site | Pori | FIN-28500 | Finland |
| Novartis Investigative Site | Beuvry | France | 62660 | France |
| Novartis Investigative Site | Angers | 49000 | France |
| Novartis Investigative Site | Briis-sous-Forges | 91640 | France |
| Novartis Investigative Site | Cournonterral | 34660 | France |
| Novartis Investigative Site | Lyon | 69317 | France |
| Novartis Investigative Site | Montpellier | 34059 | France |
| Novartis Investigative Site | Nantes | 44000 | France |
| Novartis Investigative Site | Nantes | 44300 | France |
| Novartis Investigative Site | Nîmes | 30029 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Reims | 51092 | France |
| Novartis Investigative Site | Saint-Génis-des-Fontaines | 66740 | France |
| Novartis Investigative Site | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Novartis Investigative Site | Berlin | Germany | 10117 | Germany |
| Novartis Investigative Site | Berlin | Germany | 10969 | Germany |
| Novartis Investigative Site | Berlin | Germany | 12099 | Germany |
| Novartis Investigative Site | Dresden | Germany | 01307 | Germany |
| Novartis Investigative Site | Leipzig | Germany | 04207 | Germany |
| Novartis Investigative Site | Marburg | Germany | 35037 | Germany |
| Novartis Investigative Site | Potsdam | Germany | 14467 | Germany |
| Novartis Investigative Site | Hanover | Lower Saxony | 30159 | Germany |
| Novartis Investigative Site | Peine | Lower Saxony | 31224 | Germany |
| Novartis Investigative Site | Koblenz | North Rhine-Westphalia | 56068 | Germany |
| Novartis Investigative Site | Cottbus | Saxony | 03050 | Germany |
| Novartis Investigative Site | Geesthacht | Schleswig-Holstein | 12502 | Germany |
| Novartis Investigative Site | Berlin | State of Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | State of Berlin | 10119 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Bad Wörishofen | 86825 | Germany |
| Novartis Investigative Site | Bamberg | 96049 | Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Berlin | 10789 | Germany |
| Novartis Investigative Site | Berlin | 12043 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Berlin | 13086 | Germany |
| Novartis Investigative Site | Berlin | 13156 | Germany |
| Novartis Investigative Site | Berlin | 13581 | Germany |
| Novartis Investigative Site | Bielefeld | 33617 | Germany |
| Novartis Investigative Site | Bochum | 44787 | Germany |
| Novartis Investigative Site | Bonn | 53119 | Germany |
| Novartis Investigative Site | Bonn | 53123 | Germany |
| Novartis Investigative Site | Cologne | 51069 | Germany |
| Novartis Investigative Site | Delitzsch | 04509 | Germany |
| Novartis Investigative Site | Duisburg | 47057 | Germany |
| Novartis Investigative Site | Erlangen | 91052 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Freudenberg | 57258 | Germany |
| Novartis Investigative Site | Gauting | 82131 | Germany |
| Novartis Investigative Site | Hagen | 59065 | Germany |
| Novartis Investigative Site | Halle | 06108 | Germany |
| Novartis Investigative Site | Hamburg | 20253 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hamburg | 22299 | Germany |
| Novartis Investigative Site | Hannover Münden | 34346 | Germany |
| Novartis Investigative Site | Kassel | 34121 | Germany |
| Novartis Investigative Site | Landsberg | 86899 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Lübeck | 23558 | Germany |
| Novartis Investigative Site | Minden | 32423 | Germany |
| Novartis Investigative Site | München | 80335 | Germany |
| Novartis Investigative Site | Neu-Isenburg | 63263 | Germany |
| Novartis Investigative Site | Neumünster | 24534 | Germany |
| Novartis Investigative Site | Oranienburg | 16515 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Prien A. Chiemsee | 83209 | Germany |
| Novartis Investigative Site | Ratingen | 40878 | Germany |
| Novartis Investigative Site | Reinfeld | 23858 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Schleswig | 24837 | Germany |
| Novartis Investigative Site | Schwabach | 91126 | Germany |
| Novartis Investigative Site | Solingen | 42651 | Germany |
| Novartis Investigative Site | Stade | 21680 | Germany |
| Novartis Investigative Site | Teuchern | 06682 | Germany |
| Novartis Investigative Site | Ulm | 89073 | Germany |
| Novartis Investigative Site | Warendorf | 48231 | Germany |
| Novartis Investigative Site | Weinheim | 69469 | Germany |
| Novartis Investigative Site | Wissen | 57537 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |
| Novartis Investigative Site | Athens | Greece | 12462 | Greece |
| Novartis Investigative Site | Serres | Greece | GR 62 100 | Greece |
| Novartis Investigative Site | Athens | GR | 106 76 | Greece |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Larissa | GR | 411 10 | Greece |
| Novartis Investigative Site | Rethymno | GR | 741 00 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 564 03 | Greece |
| Novartis Investigative Site | Athens | GR 115 27 | Greece |
| Novartis Investigative Site | Heraklion Crete | GR 711 10 | Greece |
| Novartis Investigative Site | Thessaloniki | GR 570 10 | Greece |
| Novartis Investigative Site | Guatemala City | Departamento de Guatemala | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | Departamento de Guatemala | 01011 | Guatemala |
| Novartis Investigative Site | Ciudad | Gautemala | 01010 | Guatemala |
| Novartis Investigative Site | Kowloon | Hong Kong | Hong Kong |
| Novartis Investigative Site | New Territories | Hong Kong | Hong Kong |
| Novartis Investigative Site | Komárom | Hungary | 2900 | Hungary |
| Novartis Investigative Site | Budapest | 1121 | Hungary |
| Novartis Investigative Site | Budapest | 1125 | Hungary |
| Novartis Investigative Site | Budapest | 1145 | Hungary |
| Novartis Investigative Site | Deszk | 6772 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Reykjavik | IS-109 | Iceland |
| Novartis Investigative Site | Hyderabad | Andhra Pradesh | 500004 | India |
| Novartis Investigative Site | Vijayawada | Andhra Pradesh | 520 002 | India |
| Novartis Investigative Site | Visakhapatnam | Andhra Pradesh | 530002 | India |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 008 | India |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 060 | India |
| Novartis Investigative Site | Gurgaon | Haryana | 122 002 | India |
| Novartis Investigative Site | Manipal | Karnataka | 576 104 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 400 012 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440010 | India |
| Novartis Investigative Site | Ludhiana | Punjab | 141001 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 641037 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 018 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 045. | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641037 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700 107 | India |
| Novartis Investigative Site | Bangalore | 560 034 | India |
| Novartis Investigative Site | Ancona | AN | 60020 | Italy |
| Novartis Investigative Site | Cassano delle Murge | BA | 70020 | Italy |
| Novartis Investigative Site | Crema | CR | 26013 | Italy |
| Novartis Investigative Site | Foggia | FG | 71100 | Italy |
| Novartis Investigative Site | Florence | FI | 50100 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Milan | MI | 20126 | Italy |
| Novartis Investigative Site | Pavullo nel Frignano | MO | 41026 | Italy |
| Novartis Investigative Site | Palermo | PA | 90146 | Italy |
| Novartis Investigative Site | Cittadella | PD | 35013 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Pordenone | PN | 33170 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Reggio Emilia | RE | 42123 | Italy |
| Novartis Investigative Site | Cuasso al Monte | VA | 21050 | Italy |
| Novartis Investigative Site | Tradate | VA | 21049 | Italy |
| Novartis Investigative Site | Negrar | VR | 37024 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Komaki | Aichi-ken | 485-0041 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 457-8511 | Japan |
| Novartis Investigative Site | Seto | Aichi-ken | 489-8642 | Japan |
| Novartis Investigative Site | Toyoake | Aichi-ken | 470-1192 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-1394 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-0033 | Japan |
| Novartis Investigative Site | Yanagawa | Fukuoka | 832-0059 | Japan |
| Novartis Investigative Site | Asahikawa | Hokkaido | 070-8644 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 062-8618 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 672-8064 | Japan |
| Novartis Investigative Site | Sakaidechō | Kagawa-ken | 762-8550 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760-8538 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0852 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-8077 | Japan |
| Novartis Investigative Site | Kōshi | Kumamoto | 861-1196 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 606-8507 | Japan |
| Novartis Investigative Site | Matsusaka | Mie-ken | 515-8544 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan |
| Novartis Investigative Site | Kishiwada | Osaka | 596-8501 | Japan |
| Novartis Investigative Site | Koshigaya | Saitama | 343-0851 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 430-8525 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 434-8511 | Japan |
| Novartis Investigative Site | Iwata | Shizuoka | 438-8550 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0027 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-8585 | Japan |
| Novartis Investigative Site | Meguro City | Tokyo | 152-8902 | Japan |
| Novartis Investigative Site | Riga | LV | LV-1038 | Latvia |
| Novartis Investigative Site | Daugavpils | LV-5401 | Latvia |
| Novartis Investigative Site | Riga | 1002 | Latvia |
| Novartis Investigative Site | Kaunas | LTU | 50009 | Lithuania |
| Novartis Investigative Site | Kaunas | LT | 50128 | Lithuania |
| Novartis Investigative Site | Vilnius | LT | 01117 | Lithuania |
| Novartis Investigative Site | Alytus | LT-62114 | Lithuania |
| Novartis Investigative Site | Kaunas | LT-45130 | Lithuania |
| Novartis Investigative Site | Klaipėda | 92288 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92231 | Lithuania |
| Novartis Investigative Site | Vilnius | 06122 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Aguascalientes | Aguascalientes | 20230 | Mexico |
| Novartis Investigative Site | Guadalajara Jalisco | Jalisco | 44220 | Mexico |
| Novartis Investigative Site | Zapopan | Jalisco | 45200 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 14050 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 14080 | Mexico |
| Novartis Investigative Site | Puebla City | Puebla | 72000 | Mexico |
| Novartis Investigative Site | Mexico City | 06726 | Mexico |
| Novartis Investigative Site | Almelo | Netherlands | 7609 PP | Netherlands |
| Novartis Investigative Site | Enschede | Netherlands | 7513 ER | Netherlands |
| Novartis Investigative Site | Harderwijk | Netherlands | 3840 AC | Netherlands |
| Novartis Investigative Site | Zutphen | Netherlands | 7207 AE | Netherlands |
| Novartis Investigative Site | Assen | 9401 RK | Netherlands |
| Novartis Investigative Site | Breda | 4818 CK | Netherlands |
| Novartis Investigative Site | Eindhoven | 5623 EJ | Netherlands |
| Novartis Investigative Site | Geldrop | 5664 EH | Netherlands |
| Novartis Investigative Site | Groningen | 9728 NT | Netherlands |
| Novartis Investigative Site | Follebu | 2656 | Norway |
| Novartis Investigative Site | Hønefoss | 3515 | Norway |
| Novartis Investigative Site | Kløfta | 2040 | Norway |
| Novartis Investigative Site | Kongsvinger | 2212 | Norway |
| Novartis Investigative Site | Skedsmokorset | 2020 | Norway |
| Novartis Investigative Site | Stavanger | 4005 | Norway |
| Novartis Investigative Site | Svelvik | 3060 | Norway |
| Novartis Investigative Site | Trondheim | 7006 | Norway |
| Novartis Investigative Site | Lipa City | Batangas | 4217 | Philippines |
| Novartis Investigative Site | Bulacan | Philippines | 3020 | Philippines |
| Novartis Investigative Site | Quezon City | 1100 | Philippines |
| Novartis Investigative Site | Bialystok | 15-010 | Poland |
| Novartis Investigative Site | Bialystok | 15-044 | Poland |
| Novartis Investigative Site | Lodz | 90-153 | Poland |
| Novartis Investigative Site | Piła | 64-920 | Poland |
| Novartis Investigative Site | Poznan | 60-569 | Poland |
| Novartis Investigative Site | Sopot | 81-741 | Poland |
| Novartis Investigative Site | Wroclaw | 51-162 | Poland |
| Novartis Investigative Site | Lisbon | Lisbon District | 1769-001 | Portugal |
| Novartis Investigative Site | Almada | Portugal | 2801-951 | Portugal |
| Novartis Investigative Site | Barcelos | Portugal | 4754-909 | Portugal |
| Novartis Investigative Site | Braga | Portugal | 4710-243 | Portugal |
| Novartis Investigative Site | Coimbra | Portugal | 3041-853 | Portugal |
| Novartis Investigative Site | Lisbon | Portugal | 1169-024 | Portugal |
| Novartis Investigative Site | Porto | Portugal | 4200-319 | Portugal |
| Novartis Investigative Site | Torres Vedras | Portugal | 2560-324 | Portugal |
| Novartis Investigative Site | Vila Franca de Xira | Portugal | 2600-009 | Portugal |
| Novartis Investigative Site | Vila Nova de Gaia | Portugal | 4434-502 | Portugal |
| Novartis Investigative Site | Viseu | Portugal | 3504-509 | Portugal |
| Novartis Investigative Site | Bucharest | District 1 | 10457 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030317 | Romania |
| Novartis Investigative Site | Craiova | Dolj | 200515 | Romania |
| Novartis Investigative Site | Iași | Jud. Iasi | 700115 | Romania |
| Novartis Investigative Site | Brasov | Romania | 500086 | Romania |
| Novartis Investigative Site | Bucharest | Romania | Romania |
| Novartis Investigative Site | Deva | Romania | 330084 | Romania |
| Novartis Investigative Site | Iași | Romania | 700305 | Romania |
| Novartis Investigative Site | Oradea | Romania | 410051 | Romania |
| Novartis Investigative Site | Târgu Mureş | Romania | 540072 | Romania |
| Novartis Investigative Site | Timișoara | Timiș County | 300310 | Romania |
| Novartis Investigative Site | Arad | 310013 | Romania |
| Novartis Investigative Site | Arad | 310086 | Romania |
| Novartis Investigative Site | Bucharest | 050159 | Romania |
| Novartis Investigative Site | Bucharest | 060011 | Romania |
| Novartis Investigative Site | Bucharest | 50159 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400371 | Romania |
| Novartis Investigative Site | Deva | 330162 | Romania |
| Novartis Investigative Site | Barnaul | 656045 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454021 | Russia |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | N.Novgorod | 603126 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344090 | Russia |
| Novartis Investigative Site | Ryazan | 390026 | Russia |
| Novartis Investigative Site | Saratov | 410012 | Russia |
| Novartis Investigative Site | Tver' | 170100 | Russia |
| Novartis Investigative Site | Ufa | 450000 | Russia |
| Novartis Investigative Site | Yaroslavl | 150030 | Russia |
| Novartis Investigative Site | Belgrade | Serbia | 11000 | Serbia |
| Novartis Investigative Site | Belgrade | Serbia | 11080 | Serbia |
| Novartis Investigative Site | Knez-Selo | 18204 | Serbia |
| Novartis Investigative Site | Kragujevac | 34000 | Serbia |
| Novartis Investigative Site | Bardejov | Slovak Republic | 085 01 | Slovakia |
| Novartis Investigative Site | Bojnice | Slovak Republic | 972 01 | Slovakia |
| Novartis Investigative Site | Humenné | Slovak Republic | 066 01 | Slovakia |
| Novartis Investigative Site | Košice | Slovak Republic | 04001 | Slovakia |
| Novartis Investigative Site | Liptovský Hrádok | Slovak Republic | 033 01 | Slovakia |
| Novartis Investigative Site | Partizánske | Slovak Republic | 958 01 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 84104 | Slovakia |
| Novartis Investigative Site | Košice | Slovakia | 040 01 | Slovakia |
| Novartis Investigative Site | Lučenec | Slovakia | 98439 | Slovakia |
| Novartis Investigative Site | Martin | Slovakia | 036 59 | Slovakia |
| Novartis Investigative Site | Považská Bystrica | Slovakia | 017 01 | Slovakia |
| Novartis Investigative Site | Námestovo | Slovensko | 02901 | Slovakia |
| Novartis Investigative Site | Košice | 040 01 | Slovakia |
| Novartis Investigative Site | Nové Zámky | 940 01 | Slovakia |
| Novartis Investigative Site | Poprad | 058 01 | Slovakia |
| Novartis Investigative Site | Spisská Nová Ves | 052 01 | Slovakia |
| Novartis Investigative Site | Berea | Durban | 4001 | South Africa |
| Novartis Investigative Site | Sandton | Gauteng | 2057 | South Africa |
| Novartis Investigative Site | Pretoria | South Africa | 0132 | South Africa |
| Novartis Investigative Site | Cape Town | 7500 | South Africa |
| Novartis Investigative Site | Cape Town | 7505 | South Africa |
| Novartis Investigative Site | Cape Town | 7531 | South Africa |
| Novartis Investigative Site | Cape Town | 7925 | South Africa |
| Novartis Investigative Site | Gatesville | 7764 | South Africa |
| Novartis Investigative Site | Port Elizabeth | 6014 | South Africa |
| Novartis Investigative Site | Pretoria | 0181 | South Africa |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Jeonju | Jeollabuk-do | 561-712 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 130-709 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 137-701 | South Korea |
| Novartis Investigative Site | Seoul | Seoul | 156-755 | South Korea |
| Novartis Investigative Site | Incheon | 403-720 | South Korea |
| Novartis Investigative Site | Seoul | 130-872 | South Korea |
| Novartis Investigative Site | Seoul | 136-705 | South Korea |
| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Sanlúcar de Barrameda | Andalusia | 11540 | Spain |
| Novartis Investigative Site | Barcelona | Barcelona | 08022 | Spain |
| Novartis Investigative Site | Torrelavega | Cantabria | 39300 | Spain |
| Novartis Investigative Site | Burgos | Castille and León | 09006 | Spain |
| Novartis Investigative Site | Ponferrada | Castille and León | 24400 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08024 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08026 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Salt | Catalonia | 17190 | Spain |
| Novartis Investigative Site | Mérida | Extremadura | 06800 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28029 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28046 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Novartis Investigative Site | Cartagena | Murcia | 30202 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03550 | Spain |
| Novartis Investigative Site | Alzira | Valencia | 46600 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Barakaldo | Vizcaya | 48903 | Spain |
| Novartis Investigative Site | Borås | 506 30 | Sweden |
| Novartis Investigative Site | Luleå | SE-971 80 | Sweden |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Stockholm | 111 57 | Sweden |
| Novartis Investigative Site | Trollhättan | 461 85 | Sweden |
| Novartis Investigative Site | Uddevalla | 451 50 | Sweden |
| Novartis Investigative Site | Taichung | Taiwan | 40705 | Taiwan |
| Novartis Investigative Site | Taipei County | Taiwan | 22060 | Taiwan |
| Novartis Investigative Site | Tainan | Taiwan ROC | Taiwan |
| Novartis Investigative Site | Chiayi County | 613 | Taiwan |
| Novartis Investigative Site | Niaosong Township | 83301 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 112 | Taiwan |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Khon Kaen | 40002 | Thailand |
| Novartis Investigative Site | Songkhla | 90110 | Thailand |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06490 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34854 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigative Site | Kinikli / Denizli | 20070 | Turkey (Türkiye) |
| Novartis Investigative Site | Manisa | 45040 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33079 | Turkey (Türkiye) |
| Novartis Investigative Site | Huntingdon | Cambridgeshire | PE29 6NT | United Kingdom |
| Novartis Investigative Site | Stockton | Cleveland | TS19 8PE | United Kingdom |
| Novartis Investigative Site | Midsomer Norton | Radstock | BA3 2UH | United Kingdom |
| Novartis Investigative Site | Axbridge | Somerset | BS26 2BJ | United Kingdom |
| Novartis Investigative Site | Taunton | Somerset | TA1 5DA | United Kingdom |
| Novartis Investigative Site | South Shields | Tyne and Wear | NE34 0PL | United Kingdom |
| Novartis Investigative Site | Cambridge | United KIngdom | CB7 5JD | United Kingdom |
| Novartis Investigative Site | Crawley | West Sussex | RH10 7DX | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2TH | United Kingdom |
| Novartis Investigative Site | Chester | CH2 1UL | United Kingdom |
| Novartis Investigative Site | Darlington | DL3 6HX | United Kingdom |
| Novartis Investigative Site | Lancashire | FY3 7EN | United Kingdom |
| Novartis Investigative Site | Leeds | LS9 7TF | United Kingdom |
| Novartis Investigative Site | London | EC14 7BE | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| Novartis Investigative Site | Tyne & Wear | NE29 8NH | United Kingdom |
| Novartis Investigative Site | Wiltshire | SN15 2SB | United Kingdom |
| Mathioudakis AG, Bate S, Sivapalan P, Jensen JS, Singh D, Vestbo J. Rethinking Blood Eosinophils for Assessing Inhaled Corticosteroids Response in COPD: A Post Hoc Analysis From the FLAME Trial. Chest. 2024 Nov;166(5):987-997. doi: 10.1016/j.chest.2024.06.3790. Epub 2024 Jul 9. |
| 32321518 | Derived | Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8. |
| 30621717 | Derived | Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7. |
| 30019939 | Derived | Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC. |
| 29925383 | Derived | Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z. |
| 28278391 | Derived | Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC. |
| 27181606 | Derived | Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15. |
| Full Analysis Set (FAS) |
|
| Per-protocol Set (PPS) |
|
| Serial Spirometry Set |
|
| Safety Set (SAF) |
|
| Urine Cortisol Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 | QVA149 (110/50 μg) once daily |
| BG001 | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | Salmeterol/fluticasone (50/500μg) twice a day |
| 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 |
| |||||||||||||||
| Sex: Female, Male | 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 COPD Exacerbations | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used. | The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included. | Posted | Least Squares Mean | 95% Confidence Interval | COPD Exacerbations/year | 52 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First COPD Exacerbation. | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate to Severe COPD Exacerbations. | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | Posted | Least Squares Mean | 95% Confidence Interval | COPD Exacerbation/year | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate to Severe COPD Exacerbation. | First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | Posted | Least Squares Mean | 95% Confidence Interval | COPD Exacerbation/year | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included . | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included. | Posted | Least Squares Mean | 95% Confidence Interval | COPD Exacerbation/year | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. | All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | Posted | Least Squares Mean | 95% Confidence Interval | COPD Exacerbation/year | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | Posted | Mean | Standard Deviation | COPD Exacerbation/year | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Posted | Median | 95% Confidence Interval | Days | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, day 1 (30 min and one hour post dose) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 26 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 38 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second | Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h) | Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time" | Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 26 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 38 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total St. George's Respiratory Questionnaire Score | The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Number of Puffs of Rescue Medication | A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in LLM are included. | Posted | Least Squares Mean | Standard Error | Number of puffs per day | Baseline, 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol. | Urine cortisol/creatinine ratio | Urine cortisol set is the subset of patients who were measured with 24-hour Urine cortisol, a subset of safety set. The safety set included all patients who received at least one dose of study drug. At the post-baseline timepoint only patients with a value at both baseline and the post-baseline timepoint are included. | Posted | Median | Full Range | ng/mL | Baseline, 52 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Vital Capacity | Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included | Posted | Least Squares Mean | Standard Error | Liters | 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events, Serious Adverse Events, and Death | The overall rate of adverse events reported from initiation through 30 days post last dose. | The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included | Posted | Number | Number of participants | 52 weeks of treatment + 30 days |
|
|
Not provided
Not provided
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 | QVA149 | QVA149 (110/50 μg) once daily | 308 | 1,678 | 1,363 | 1,678 | ||
| EG001 | Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS) | Salmeterol/fluticasone (50/500μg) twice a day | 334 | 1,680 | 1,424 | 1,680 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| HEPARIN-INDUCED THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| HYPOCHROMIC ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIOVASCULAR DISORDER | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CONGESTIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| COR PULMONALE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| COR PULMONALE CHRONIC | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ISCHAEMIC CARDIOMYOPATHY | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL RUPTURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| PERICARDIAL HAEMORRHAGE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| PROGRESSIVE CEREBELLAR DEGENERATION | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| GOITRE | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| ANGLE CLOSURE GLAUCOMA | Eye disorders | MedDRA | Systematic Assessment |
| |
| OPHTHALMOPLEGIA | Eye disorders | MedDRA | Systematic Assessment |
| |
| OPTIC ISCHAEMIC NEUROPATHY | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ACID PEPTIC DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| SUDDEN CARDIAC DEATH | General disorders | MedDRA | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| HEPATIC CYST RUPTURED | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| FOOD ALLERGY | Immune system disorders | MedDRA | Systematic Assessment |
| |
| ABSCESS JAW | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ATYPICAL MYCOBACTERIAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ECZEMA INFECTED | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS ROTAVIRUS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTED SKIN ULCER | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTIVE ANEURYSM | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| MENINGITIS VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ORAL VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| OTITIS EXTERNA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| OTITIS MEDIA CHRONIC | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMOCOCCAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PSEUDOMONAS INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SPUTUM PURULENT | Infections and infestations | MedDRA | Systematic Assessment |
| |
| TUBERCULOUS PLEURISY | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URETERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| BRAIN HERNIATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CARBON MONOXIDE POISONING | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| POSTOPERATIVE WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| PROCEDURAL INTESTINAL PERFORATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| WOUND DECOMPOSITION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DIET REFUSAL | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| OSTEOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| POLYMYALGIA RHEUMATICA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| ADRENAL GLAND CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | 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 |
| |
| BRONCHIAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| CHRONIC MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| DIFFUSE LARGE B-CELL LYMPHOMA | 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 |
| |
| HEPATIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| HYPOPHARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LARGE INTESTINE BENIGN NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LARYNGEAL SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| MALIGNANT MESENCHYMOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| PENILE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SMALL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| URETHRAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| BASAL GANGLIA STROKE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| BRAIN INJURY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| BRAIN STEM HAEMORRHAGE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CAROTID ARTERIOSCLEROSIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CAROTID ARTERY OCCLUSION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM LESION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBELLAR INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL THROMBOSIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CLUSTER HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DELIRIUM TREMENS | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| URETHRAL STENOSIS | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| TESTICULAR TORSION | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| BRONCHOPLEURAL FISTULA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HYPERCAPNIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| LARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMOTHORAX SPONTANEOUS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY HILAR ENLARGEMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY ACIDOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| LINEAR IGA DISEASE | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| PARAPSORIASIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA | Systematic Assessment |
| |
| AORTIC ANEURYSM RUPTURE | Vascular disorders | MedDRA | Systematic Assessment |
| |
| AORTIC CALCIFICATION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| EMBOLISM ARTERIAL | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| LERICHE SYNDROME | Vascular disorders | MedDRA | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA | Systematic Assessment |
| |
| PERIPHERAL EMBOLISM | Vascular disorders | MedDRA | Systematic Assessment |
| |
| TEMPORAL ARTERITIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| VARICOSE ULCERATION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL CANDIDIASIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| SPUTUM INCREASED | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| 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
| ID | Term |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Physician Decision |
|
| Protocol deviation |
|
| Technical problems |
|
| Male |
|
| Generalized linear method |
| 0.003 |
| Rate Ratio |
| 0.89 |
| 2-Sided |
| 95 |
| 0.83 |
| 0.96 |
If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1. |
| No |
| Superiority or Other |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
|