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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT01343251
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01343251
Study Brief: HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control HeRO eligible patients who did not receive a HeRO Graft None None 15 17 0 17 View
HeRO Graft HeRO Graft recipients None None 16 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death-Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death-Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death-Unknown Cause SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury-Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Peripheral Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Access Creation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Access Exchange SYSTEMATIC_ASSESSMENT Vascular disorders None View
Access Explant SYSTEMATIC_ASSESSMENT Vascular disorders None View
Access Revision SYSTEMATIC_ASSESSMENT Vascular disorders None View
Graft Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intervention to Restore Patency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arteriosclerotic Heart Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):