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: 2025-12-24 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT04132466
Description: Adverse events in this study were limited to adverse device effects (ADEs). An ADE was defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator is at least possibly related to use of the Test System during the study procedure. Anticipated adverse device effects were specified in the study protocol based on risk assessment.
Frequency Threshold: 0
Time Frame: During the study procedure or observed during clinical follow-up within one week post procedure.
Study: NCT04132466
Study Brief: ASSURE WCD Clinical Evaluation - Conversion Efficacy 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
Enrolled Subjects Adult subjects who met eligibility criteria and provided written informed consent to participate Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system: defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator 0 None 0 13 3 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Redness/Irritation (Anticipated Adverse Device Effect) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View