Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
NCT ID:
NCT02059057
Description:
Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
Frequency Threshold:
5
Time Frame:
12 months
Study:
NCT02059057
Study Brief:
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LVRC System | The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use. | 9 | None | 56 | 101 | 97 | 101 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Aortic Valve Stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Cor Pulmonale | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Coronary Artery Occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (15.0) | View |
| Diabetic Gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Megacolon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Medical Device Complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (15.0) | View |
| Aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Infective Exacerbation of COPD | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Thoracic Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (15.0) | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pleuritic Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Pulmonary Haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Respiratory Distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.0) | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Medical Device Complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |