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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001998-93 |
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This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 dose 1 | Experimental | QVA149 27.5/12.5 μg capsules |
|
| QVA149 dose 2 | Experimental | QVA149 27.5/25 μg capsules |
|
| QAB149 | Active Comparator | QAB149 75 μg capsules |
|
| 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 Concept1 SDDPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Premature Discontinuation of Treatment | methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl | 56 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Vestavia Hills | Alabama | 35216 | United States | ||
| Novartis Investigative Site |
Six hundred fifteen patients were randomized. One patient was randomized but did not receive treatment due to an adverse event. In the safety set, patients were analyzed according to the treatment received. Therefore, protocol enrollment and analysis set was 614 but the participant flow was 615
Patients were randomized to each treatment arm in 1:1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 27.5/12.5 ug Bid | |
| FG001 | QVA149 27.5/25 ug Bid | |
| FG002 | QAB149 75 ug od |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| QVA149 | Drug | QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI |
|
| QAB149 | Drug | QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI |
|
| Placebo | Drug | To mimic QAB149 |
|
| Change From Baseline in Pre-dose Trough FEV1 |
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. |
| Day 29, 57,, 85, 141, 197, 253, 309 and 365 |
| Change From Baseline in 1 Hour Post-dose FEV1 Measurements | 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. | Day 1, 29, 57, 85, 141, 197, 253, 309, and 365 |
| Change From Baseline in FVC Measurement at All Post-baseline Time Points | Pulmonary function assessments were performed using centralized spirometry according to international standards. | Day1, 29, 57, 85, 141, 197, 253, 309, and 365 |
| Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation | Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD) | 52 weeks |
| Change From Baseline in Mean Total Daily Symptom Scores | The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement. | 52 weeks |
| Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period | Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. | 52 weeks |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Novartis Investigative Site | Lakewood | California | 90712-151 | United States |
| Novartis Investigative Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Walnut Creek | California | 94598 | United States |
| Novartis Investigative Site | Boulder | Colorado | 80304 | United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Novartis Investigative Site | Lombard | Illinois | 60148 | United States |
| Novartis Investigative Site | O'Fallon | Illinois | 62269 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61602 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47712 | United States |
| Novartis Investigative Site | Ames | Iowa | 50010 | United States |
| Novartis Investigative Site | Iowa City | Iowa | 52240 | United States |
| Novartis Investigative Site | Waterloo | Iowa | 50702 | United States |
| Novartis Investigative Site | Bowling Green | Kentucky | 42101 | United States |
| Novartis Investigative Site | New Orleans | Louisiana | 70115 | United States |
| Novartis Investigative Site | Slidell | Louisiana | 70458 | United States |
| Novartis Investigative Site | Bangor | Maine | 04401 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21224 | United States |
| Novartis Investigative Site | Livonia | Michigan | 48152 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55407 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | United States |
| Novartis Investigative Site | Saint Charles | Missouri | 63301 | United States |
| Novartis Investigative Site | Missoula | Montana | 59804 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68506 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | United States |
| Novartis Investigative Site | Henderson | Nevada | 89014 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89119 | United States |
| Novartis Investigative Site | Rochester | New York | 14618 | United States |
| Novartis Investigative Site | Dayton | Ohio | 45459 | United States |
| Novartis Investigative Site | Dublin | Ohio | 43016 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97404 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504-8741 | United States |
| Novartis Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37912 | United States |
| Novartis Investigative Site | Corsicana | Texas | 75110 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Lufkin | Texas | 75904 | United States |
| Novartis Investigative Site | McKinney | Texas | 75069 | United States |
| Novartis Investigative Site | Abingdon | Virginia | 24210 | United States |
| Novartis Investigative Site | Midlothian | Virginia | 23114 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23606 | United States |
| Novartis Investigative Site | Rousse | Bulgaria | 7002 | Bulgaria |
| Novartis Investigative Site | Sofia | Bulgaria | 1431 | Bulgaria |
| Novartis Investigative Site | Varna | Bulgaria | 9010 | Bulgaria |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Helsinki | Finland | 00029 | Finland |
| Novartis Investigative Site | HUS | 00029 | Finland |
| Novartis Investigative Site | Pori | FIN-28500 | Finland |
| Novartis Investigative Site | Turku | 20521 | Finland |
| Novartis Investigative Site | Nyíregyháza | Hungary | 4400 | Hungary |
| Novartis Investigative Site | Budapest | 1046 | Hungary |
| Novartis Investigative Site | Budapest | 1125 | Hungary |
| Novartis Investigative Site | Győr | 9024 | Hungary |
| Novartis Investigative Site | Makó | 6900 | Hungary |
| Novartis Investigative Site | Pécs | 7635 | Hungary |
| Novartis Investigative Site | Százhalombatta | 2440 | Hungary |
| Novartis Investigative Site | Szolnok | H-5000 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Barceloneta | 00617 | Puerto Rico |
| Novartis Investigative Site | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | San Juan | 00918 | Puerto Rico |
| Novartis Investigative Site | Bucharest | District 1 | 10457 | Romania |
| Novartis Investigative Site | Bucharest | District 1 | 11475 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030303 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030317 | Romania |
| Novartis Investigative Site | Constanța | Jud. Constanta | 900002 | Romania |
| Novartis Investigative Site | Iași | Jud. Iasi | 700115 | Romania |
| Novartis Investigative Site | Brasov | Romania | 500281 | Romania |
| Novartis Investigative Site | Bucharest | 060011 | Romania |
| Novartis Investigative Site | Bucharest | 50554 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400371 | Romania |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Badalona | Catalonia | 08914 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | Spain |
| Novartis Investigative Site | Canet de Mar | Catalonia | 08360 | Spain |
| Novartis Investigative Site | Centelles | Catalonia | 08540 | Spain |
| Novartis Investigative Site | Tarragona | Catalonia | 43350 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46015 | Spain |
| Safety Set |
|
| Full Analysis Set (FAS) |
|
| Randomized Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment they were assigned to at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 27.5/12.5 ug Bid | |
| BG001 | QVA149 27.5/25 ug Bid | |
| BG002 | QAB149 75 ug od | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | 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 Patients | 56 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Premature Discontinuation of Treatment | methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl | The Safety set consisted of 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. | Posted | Median | 95% Confidence Interval | Days | 56 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pre-dose Trough FEV1 | 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 Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Least Squares Mean | Standard Error | Liters | Day 29, 57,, 85, 141, 197, 253, 309 and 365 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 1 Hour Post-dose FEV1 Measurements | 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 Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Least Squares Mean | Standard Error | Liters | Day 1, 29, 57, 85, 141, 197, 253, 309, and 365 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in FVC Measurement at All Post-baseline Time Points | Pulmonary function assessments were performed using centralized spirometry according to international standards. | The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Least Squares Mean | Standard Error | Liters | Day1, 29, 57, 85, 141, 197, 253, 309, and 365 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation | Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD) | The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. | Posted | Number | Percentage of participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Total Daily Symptom Scores | The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement. | The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Least Squares Mean | Standard Error | Score on a scale | 52 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period | Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. | The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized. | Posted | Least Squares Mean | Standard Error | Number of puffs | 52 weeks |
|
|
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 27.5/12.5 ug Bid | 26 | 204 | 118 | 204 | |||
| EG001 | QVA149 27.5/25 ug Bid | 25 | 204 | 117 | 204 | |||
| EG002 | QAB75 | QVA149 27.5/25 μg capsules | 24 | 206 | 112 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| SILENT MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ASPLENIA | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INGUINAL HERNIA STRANGULATED | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| FACIAL PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| H1N1 INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | 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 |
| |
| BRAIN HERNIATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| BONE CANCER | 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 |
| |
| KAPOSI'S SARCOMA | 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 |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO PERITONEUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO SPINE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER STAGE IV | 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 |
| |
| RENAL CELL CARCINOMA | 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 |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PANIC ATTACK | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| AORTIC DISSECTION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | 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 |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VOMITING | 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 |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PHARYNGITIS | 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 |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric 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 |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | 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 |
| C510790 | indacaterol |
Not provided
Not provided
Not provided
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