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 @ 6:48 PM
Ignite Modification Date:
2025-12-25 @ 4:19 PM
NCT ID:
NCT05734157
Description:
None
Frequency Threshold:
0
Time Frame:
Baseline to 12 months
Study:
NCT05734157
Study Brief:
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Everolimus-coated Balloon | Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon. | 3 | None | 37 | 75 | 51 | 75 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Death during heart surgery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Heart attack | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Partial Infarct | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Right ventricular implant repair | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Colon tumor | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Epigastric pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Inflammatory bladder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Cancer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Terminal cancer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Aneurysm spurium | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Distal embolism | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Revascularization | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Spinal contusions | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Parkinson's Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Stenosis, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Stenosis, non-study vessel | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Stenosis, non-target lesion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Stenosis, target vessel | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| COPD | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Nasal resection (squamous cell cancer) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Glaucoma surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| CRP increase at discharge | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Irregular heartrate | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Thoracic pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Burning pain in esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Esophageal reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Bruising/hemotoma over body | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Calf claudication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Calf pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Deep vein thrombosis, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Diabetes mellitus II | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Distal arteriopathy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Dizzyness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Groin bleeding | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Groin/scrotum hematoma (non-study limb) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Haematoma, right arm | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Haematoma, wrist | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Hip pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Knee injury | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Knee pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Leg claudication, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Leg oedema, both legs | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Leg pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Lower body/limbs hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Lower leg swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Necrosectomy, heel | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Oedema, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Pain, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Polyneuropathy, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Stenosis, non-TL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Stenosis, non-study limb | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| TL occlusion, no action taken | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Teeth extraction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Tingling/numbing foot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Toe pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Covid | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| AV fistula post-dilatation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Bleeding at groin puncture site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Distal embolism | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Groin pain at puncture site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Hematoma at puncture site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Pain in lower leg | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Disc prolapse | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Sciatica pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Spinal canal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Chronic kidney insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Skin tumor | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Allergy to medication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Angiography performed | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Bruises easily | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Swollen knee | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Perforation from guidewire | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Superficial thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |