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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT03319160
Description: Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.
Frequency Threshold: 0
Time Frame: Data was collected until the end of the prescribed WCD use time (typically 3 months).
Study: NCT03319160
Study Brief: LifeVest Safety and Efficacy in Real Life Settings in France
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All LifeVest Users Patients who were prescribed and used a LifeVest in France Wearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention 26 None 6 1157 0 1157 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inappropriate shocks SYSTEMATIC_ASSESSMENT Product Issues None View
Allergy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea with device alerts SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):