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: 2025-12-24 @ 1:10 PM
Ignite Modification Date: 2025-12-25 @ 12:22 PM
NCT ID: NCT03807661
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT03807661
Study Brief: Percutaneous Deep Vein Arterialization Post-Market 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
Percutaneous Deep Vein Arterialization Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach 4 None 26 28 19 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arterial or venous occlusion (target limb) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound healing disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
New wound or ulcer NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding (non-target limb) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gangrene or necrosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other blood flow abnormality (target limb) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain (target limb) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis or systemic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Access site bleeding or hematoma NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Anemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cardiac rhythm disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoglycemia or hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Mitral valve regurgitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain (non-target limb) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac rhythm disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial or venous occlusion (target limb) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bleeding (non-target limb) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Edema NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypoglycemia or hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
New wound or ulcer NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain (target limb) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View