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: 2025-12-25 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT03263702
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03263702
Study Brief: RADAR Clinical 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
De Novo Participants with 1st procedure 0 None 10 38 8 38 View
Re-Do Ablation Participants who need a re-do ablation procedure 0 None 5 26 3 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening heart failure with influenza SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Upper GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Amiodarone Intolerance SYSTEMATIC_ASSESSMENT General disorders None View
Blood in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non-sustained Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis with lower back abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
COPD Exacebation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath and abdominal rash SYSTEMATIC_ASSESSMENT General disorders None View
Amiodarone induced ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroesophageal bleed with hypotension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Prostatectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pseudoaneurysm of right femoral artery SYSTEMATIC_ASSESSMENT Vascular disorders None View
Severe Mitral Valve Regurgitation, and Paroxysmal Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Severe three vessel coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cogitive Decline SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical flutter with RVR SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower extremity edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Recurrent Left Pleural Effusions SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo (Labyrinthitis) SYSTEMATIC_ASSESSMENT General disorders None View
VF with ICD Shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Symptomatic PVCs SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vaginitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View