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 @ 3:36 PM
Ignite Modification Date: 2025-12-25 @ 1:48 PM
NCT ID: NCT02096692
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02096692
Study Brief: ProMRI Study of the Iforia ICD System (Phase C)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ICD System Therapy Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine None None 23 154 24 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Thrombosis SYSTEMATIC_ASSESSMENT General disorders None View
Medication Related SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal Pain or Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral Vascular Disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Obstructive Sleep Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope/Pre-Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening Chronic Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
MRI Incidental Finding SYSTEMATIC_ASSESSMENT General disorders None View