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 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
NCT ID:
NCT02215369
Description:
The safety population was used for all adverse event reporting and analyses.
Frequency Threshold:
0
Time Frame:
12 months
Study:
NCT02215369
Study Brief:
SeCure Endovenous Laser Treatment Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| VenaCure EVLT 400 µm Fiber Procedure Kit (Safety Population) | Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule. VenaCure EVLT 400 µm fiber Procedure Kit: The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit. | 1 | None | 9 | 93 | 26 | 93 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Immune thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (18.0) | View |
| Peripheral venous disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Pneumonia legionella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Adenocarcinoma gastric | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Angiodermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Skin injury | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Knee arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.0) | View |
| Arterial restenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Bleeding varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Thrombophlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Venous occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |