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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT00355056
Description: None
Frequency Threshold: 5
Time Frame: All adverse events were collected from the time of signing informed consent until the 12-month follow-up visit. After the 12-month follow-up visit, serious adverse events and/or device-related events were collected until completion of study requirements.
Study: NCT00355056
Study Brief: PREMIUM Migraine Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PFO Device Closure PFO device Closure procedure using the AMPLATZER PFO Occluder device. None None 1 123 119 123 View
Sham Procedure Did not receive the closure device, and treated with the current standard of care medical treatment. None None 0 107 103 107 View
Optional PFO Closure Subjects randomized to the sham arm and completed their 12-month follow up visit were given the option of PFO closure with the Amplatzer PFO Occluder. None None 0 87 68 87 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient atrial fibrillation after device placement None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arterial Hypertension/Hypertension None Cardiac disorders None View
Nausea None General disorders None View
Fatigue/Generalized Fatigue None General disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal Pain None General disorders None View
Common cold/Upper Respiratory Tract Infection None Infections and infestations None View
Abdominal Pain None Gastrointestinal disorders None View
Anxiety None General disorders None View
Rash None General disorders None View
Pain None General disorders None View
Urinary Tract Infection None Infections and infestations None View
Diarrhea None Gastrointestinal disorders None View
Dizziness None General disorders None View
Palpitations None Cardiac disorders None View
Sinusitis None General disorders None View
Chest Pain None General disorders None View
Vascular Access Site Complication Pain None Vascular disorders None View
Bruise/Purpura Simplex None General disorders None View
Viral Syndrome None General disorders None View
Low Back Pain None General disorders None View
Back Pain None General disorders None View
Vascular Access Site Complication Hematoma None Vascular disorders None View
Vascular Access Site Complication Bruise None Vascular disorders None View
Mid-Sternal Chest Pressure None General disorders None View
Headache None General disorders None View
Depression None General disorders None View
Dyspnea None General disorders None View
Sore Throat None General disorders None View
Vascular Access Site Complication Bleeding None Vascular disorders None View