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 @ 4:51 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT01736618
Description: None
Frequency Threshold: 1
Time Frame: Data was collected over a 60 month (5-year) follow-up period
Study: NCT01736618
Study Brief: S-ICD® System Post Approval Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
S-ICD System Implant Attempt All subjects undergo an S-ICD System implant procedure. 294 None 638 1766 247 1766 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Supraventricular Tachycardia (SVT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Inflammation - Cardiovascular related SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Multisystem Failure - Other SYSTEMATIC_ASSESSMENT General disorders None View
Death - unknown cause SYSTEMATIC_ASSESSMENT General disorders None View
Syncope - Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Near Syncope/Dizziness/Shortness of Breath/Confusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Near Syncope/Dizziness/Shortness of Breath/Confusion SYSTEMATIC_ASSESSMENT General disorders None View
Other - Patient Condition - Non-cardiovascular SYSTEMATIC_ASSESSMENT General disorders None View
Infection - Non-device/procedure related SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection - S-ICD System/Implant Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma <= 30 days post-implant - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection - Incisional/Superficial Infection - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Adverse Reaction - Hypotension - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Discomfort - Post-op > 30-Days - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Sub-optimal Electrode Position - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Adverse Reaction to Medications - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Elective Device Replacement SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Electrode Movement - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Inadequate healing of incision site - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Adverse Reaction Respiratory - Procedure Related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bleeding - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fever - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heart Failure / Worsening of Heart Failure - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma - Pocket (> 30 days post-implant) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma > 30 days post-implant - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PG movement / Revision - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pleural Effusion - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pneumothorax - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulseless Electrical Activity (PEA) Post Anesthesia prior to Implant SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sub-optimal device and electrode position - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Unable to Convert - During Device System Implant Procedure SYSTEMATIC_ASSESSMENT Product Issues None View
Erosion - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Appropriate Shock - Accelerated Arrhythmia SYSTEMATIC_ASSESSMENT Product Issues None View
Electrode Conductor Fracture- Presumed Twiddler's Syndrome SYSTEMATIC_ASSESSMENT Product Issues None View
Erosion - Electrode related SYSTEMATIC_ASSESSMENT Product Issues None View
Erosion - Imminent Erosion - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Inability to Communicate with the Device SYSTEMATIC_ASSESSMENT Product Issues None View
Inappropriate Shock - Inappropriate Sensing: Baseline Shift SYSTEMATIC_ASSESSMENT Product Issues None View
Trauma to Device SYSTEMATIC_ASSESSMENT Product Issues None View
Unable to Convert - During Device Testing Procedure >150 days - Patient condition SYSTEMATIC_ASSESSMENT Product Issues None View
Undersensing - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Psychological Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of Breath/Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stroke - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral Vascular Disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Transient Ischemic Attack (TIA) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Discomfort - Post-op ≤ 30-Days - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Discomfort - Post-op ≤ 30-Days - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Device Movement - Revision SYSTEMATIC_ASSESSMENT Product Issues None View
Electrode movement - Electrode related SYSTEMATIC_ASSESSMENT Product Issues None View
Respiratory Failure - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Inappropriate Shock - Above Programmed Rate Zone SYSTEMATIC_ASSESSMENT Product Issues None View
Premature Cell Battery Depletion SYSTEMATIC_ASSESSMENT Product Issues None View
Inappropriate Shock - Inappropriate Sensing: Discrimination Error SYSTEMATIC_ASSESSMENT Product Issues None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart Failure (HF)/ Worsening HF SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening VT/VF SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain - Cardiovascular related SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation / Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia/ AV Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulseless Electrical Activity (PEA) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other -Cardiovascular related SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature Ventricular Contractions (PVC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope - Non-cardiovascular SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain - Non-cardiac other SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal Laboratory Values SYSTEMATIC_ASSESSMENT General disorders None View
Trauma - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac arrest - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Discomfort - Post-op > 30-Days - Device related SYSTEMATIC_ASSESSMENT Product Issues None View
Incisional/Superficial Infection - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma <= 30 days post-implant - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Discomfort - Post-op ≤ 30-Days - Procedure related SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View