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 @ 12:20 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT02165761
Description: None
Frequency Threshold: 5.0
Time Frame: 2 years, 3 months
Study: NCT02165761
Study Brief: Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hybrid Vascular Graft (Test) Hybrid Vascular Graft (Test) 1 None 6 23 4 23 View
Non-Heparin Synthetic Graft (Control) Non-Heparin Synthetic Graft (Control) 1 None 5 19 8 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
Cellulitis of legs SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Graft infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Unsteady gait SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View
Weakness SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Sigmoid diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 20.0 View
Motor vehicle accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Vascular graft occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Adult failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 20.0 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 20.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Pleural effusion recurrent SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arteriovenous graft thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Venous pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 20.0 View
Numbness in hand SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 20.0 View
COPD exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 20.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0 View
Steal syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0 View
Peripheral edema SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 20.0 View