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 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
NCT ID:
NCT01085435
Description:
None
Frequency Threshold:
0
Time Frame:
From enrollment to 5-year annual visit.
Study:
NCT01085435
Study Brief:
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| EFFORTLESS Main Study | Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study. S-ICD System: The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool. | 91 | None | 199 | 984 | 531 | 984 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bleeding (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Implant/Replacement of Any Concomitant Device | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fracture/Broken Bone | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Kidney Disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Trauma (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| HEENT Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Metabolic Disorder | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Multi-system Failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other: Cardiac (Non-System/Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Shock: Cardiac Oversensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Shock: Non-Cardiac Oversensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| PG Movement | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Erosion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inability to Communicate with the Device | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fear of Shocks | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Imminent Erosion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Suspected Device Malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Incision/Superficial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| System Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Atrial Fibrillation/Flutter (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Sub-optimal Electrode position | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction (Medications) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Adverse Reaction (General) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Electrode Movement | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Bleeding (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Postoperative Limited Emphysema | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Atrial Fibrillation/Flutter (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure/Worsening of Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Syncope (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Worsening of VT/VF | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest Pain (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral Vascular Disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Bradycardia/AV Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Right Bundle Branch Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Stroke (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Infection not related to S-ICD System | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Psychological Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pneumothorax (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| GI Disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abnormal Thyroid Condition | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Unable to Convert: During Procedure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Adverse Reaction (Bradycardia) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inappropriate Shock: Non-Cardiac Oversensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Adverse Reaction (Medications) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inappropriate Shock: Discrimination Error | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Adverse Reaction (Respiratory) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Phantom Shock | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Atrial Fibrillation/Flutter (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Premature Cell Battery Depletion: Random Component Failure | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Bleeding (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| PG Movement | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inability to Communicate with the Device | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Phantom Vibration | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Phantom Beeps | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Erosion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Imminent Erosion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Electrode Movement | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fear of Shocks | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Electrode damaged and replaced during concomitant device procedure | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Suspected Device Malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Undersensing: Defibrillation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fluid Accumulation (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Programmer/Software Error code | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Post Shock Pacing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inadequate Pocket Size | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inadequate/Prolonged Healing of Incision Site | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Incision/Superficial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Keloid | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Nerve Damage (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| System Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sub-optimal Electrode position | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Syncope (Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Sub-optimal PG position | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Sub-optimal PG and Electrode position | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Redness/Irritation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Subcutaneous Emphysema | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Suture Discomfort | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Device Malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other (Procedure related: PG) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Other (Procedure related: Electrode) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Atrial Fibrillation/Flutter (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Heart Failure/Worsening of Heart Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Syncope (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Near Syncope/Dizziness/Shortness of Breath/Confusion (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| VT below Conditional Zone | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Worsening of VT/VF | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest Pain (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral Vascular Disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Bradycardia/AV Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Inflammation (Cardiac) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Right Bundle Branch Block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Stroke (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Syncope (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Infection not related to S-ICD System | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hematoma (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hematoma (Post Explant of S-ICD System) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Near Syncope/Dizziness/Shortness of Breath/Confusion (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Psychological Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Acute Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pleural Effusion (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| GI Disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abnormal Thyroid Condition | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bleeding (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nausea/Vomiting | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Repositioning of Any Concomitant Device | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Implant/Replacement of Any Concomitant Device | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inflammation (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fracture/Broken Bone | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Kidney Disease | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Trauma (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| HEENT Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Fluid Accumulation (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flu | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Genital/Urinary | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neurological | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Metabolic Disorder | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Abnormal Lab Values | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Mitral Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other: Cardiac (Non-System/Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Unable to Convert: During Procedure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adverse Reaction (Medications) (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Altered Mental Status | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Muscle Stimulation (Non-System/Non-Procedure related) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| SVT | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unable to Convert: During Spontaneous Episode | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Premature Cell Battery Depletion: Premature Declaration | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappr. Shock: Conv. bef. shock (Normal Function) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Inappropriate Shock: Cardiac Oversensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | None | View |