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 @ 12:19 AM
Ignite Modification Date: 2025-12-25 @ 10:22 PM
NCT ID: NCT02121158
Description: None
Frequency Threshold: 0
Time Frame: Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.
Study: NCT02121158
Study Brief: Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Optimal Medical Therapy Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke. 23 None 67 85 1 85 View
Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads. 20 None 62 82 6 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v23.1 View
Infection (ICD) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.1 View
Infection (other) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v23.1 View
Lead Alteration SYSTEMATIC_ASSESSMENT Product Issues MedDRA v23.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v23.1 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.1 View
Atrial fibrillation / Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.1 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.1 View
HF Complication SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Painful implant site SYSTEMATIC_ASSESSMENT General disorders MedDRA v23.1 View
New dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v23.1 View