Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT03055858
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03055858
Study Brief: AMPLATZER Duct Occluder II Additional Sizes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PDA Closure ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). 9 None 13 200 26 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Procedural Blood Loss SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Coarctation of Aorta SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Obstruction of The Aorta SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pulmonary Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Desaturation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Device Migration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Death Related to Liver Failure and Chronic Lung Disease SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Progressive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory Compromise SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Necrotizing Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Device Embolization SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Left Vocal Cord Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Obstruction of The Pulmonary Artery SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Thrombus SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Valve Damage SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Valvular Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vascular Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vessel Damage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Deterioration in Resp Status SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Right bundle branch block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory Compromise SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Anemia Requiring Transfusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Hoarse Cry SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Tissue from Left Side of Atrial Septum SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Device Embolization SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View