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 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
NCT ID:
NCT04798768
Description:
Adverse event data includes Serious/ non-serious, related/ unrelated to device were to be reported to Boston Scientific by investigational sites. All-cause mortality evaluated in all enrolled subjects (N=297). Adverse Events were evaluated in subjects implanted or attempted with S-ICD and/ or EMPOWER Leadless Pacemaker (N=288).
Frequency Threshold:
0
Time Frame:
Entire available follow up: implant through 3.5 years to-date (median participant follow up = 1.3 years)
Study:
NCT04798768
Study Brief:
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MODULAR ATP Study Participants | All-cause mortality evaluated in all enrolled participants (N=297). Adverse events were evaluated for participants implanted or attempted with the mCRM Therapy System (S-ICD after study enrollment, and/ or the EMPOWER LP), N=288. Individual adverse event categories evaluated in participants at risk for that event category (287 Leadless Cardiac Pacemaker, 9 TV Lead Extraction Procedure, 288 remaining adverse event categories). | 18 | None | 113 | 288 | 86 | 288 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Blood and Lymphatic System Disorders | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal Disorders | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | General Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Infections and Infestations | MedDRA (Unspecified) | View |
| Leadless Cardiac Pacemaker - Procedure | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| S-ICD System Patient Related | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| S-ICD System Procedure | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| TV Lead Extraction Procedure | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| Leadless Cardiac Pacemaker - Right Ventricle - Brady | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| Modular System (LCP+S-ICD) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD PG | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD System Diagnosis | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD System Therapy | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Renal and Urinary Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Respiratory, Thoracic and Mediastinal Disorders | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Vascular Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Endocrine Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | General Disorders | MedDRA (Unspecified) | View |
| S-ICD Defibrillation and Conversion Testing | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Nervous System Disorders | MedDRA (Unspecified) | View |
| S-ICD Electrode | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Skin and Subcutaneous Tissue Disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal Disorders | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | General Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | General Disorders | MedDRA (Unspecified) | View |
| S-ICD System Patient Related | NON_SYSTEMATIC_ASSESSMENT | General Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Infections and Infestations | MedDRA (Unspecified) | View |
| Leadless Cardiac Pacemaker - Procedure | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| Leadless Cardiac Pacemaker - Right Ventricle - Brady | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| S-ICD Defibrillation and Conversion Testing | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| S-ICD System Patient Related | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Cardiac Disorders | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Endocrine Disorders | MedDRA (Unspecified) | View |
| S-ICD System Procedure | NON_SYSTEMATIC_ASSESSMENT | Injury, Poisoning and Procedural Complications | MedDRA (Unspecified) | View |
| Non-cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and Connective Tissue Disorders | MedDRA (Unspecified) | View |
| Modular System (LCP+S-ICD) | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD Electrode | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD PG | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| S-ICD System Therapy | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (Unspecified) | View |
| Cardiovascular | NON_SYSTEMATIC_ASSESSMENT | Vascular Disorders | MedDRA (Unspecified) | View |