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 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
NCT ID:
NCT02907203
Description:
None
Frequency Threshold:
5
Time Frame:
2 Years
Study:
NCT02907203
Study Brief:
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Drug Coated Balloon | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. | 1 | None | 27 | 52 | 13 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coagulation disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 24.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Mitral valve insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Multiple vessel coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Non STEMI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Triple vessel disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.1 | View |
| Cataract (right) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 24.1 | View |
| Esophagitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.1 | View |
| Aspiration pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.1 | View |
| Perineal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.1 | View |
| Fracture of pelvis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Fractured ribs | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Lumbar vertebral fracture L3 | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Peripheral arterial reocclusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Post angioplasty restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Second degree burns | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Shoulder fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Superficial femoral arterial restenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | View |
| Diabetes mellitus aggravated | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.1 | View |
| Limb hyperextension | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | View |
| Basal cell carcinoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | View |
| Bleeding intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.1 | View |
| Nerve root impingement | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.1 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 24.1 | View |
| Vaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 24.1 | View |
| Adventitial cystic disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Femoral artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Femoral artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Femoropopliteal stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Iliac artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Iliac artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Peripheral artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Peripheral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
| Peripheral artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.1 | View |
Other Events(If Any):