Adverse Events Module

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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: 2025-12-25 @ 3:25 AM
Ignite Modification Date: 2025-12-26 @ 2:05 AM
NCT ID: NCT02400905
Description: Site reported serious adverse events.
Frequency Threshold: 5
Time Frame: 36 months
Study: NCT02400905
Study Brief: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BioMimics 3D Stent Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System 24 None 164 271 177 271 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Restenosis of treated segment SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial stenosis (non-target) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Restenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Restenosis of treated vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Limb ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abrupt occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Amputation (unplanned, spontaneous) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection (≥ Grade C) in target vessel requiring intervention SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolization, distal SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Total occlusion of the peripheral artery SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive heart failure (CHF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastro-intestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection (UTI) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arterial occlusion/thrombus at puncture site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Groin hematoma ≥ 5 cm, with or without surgical repair SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke or other neurological complications SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal failure/renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergic reaction (medication, contrast media, device, etc.) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Amputation (planned) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding from anticoagulant or antiplatelet medications s SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haemorrhage, with or without transfusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Death (MAE if cardiovascular-related) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Transient ischemic attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infected peripheral wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial stenosis (non-target) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Restenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Restenosis of treated segment SYSTEMATIC_ASSESSMENT Vascular disorders None View
Restenosis of treated vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular access complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View