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: 2025-12-26 @ 1:18 PM
Ignite Modification Date: 2025-12-26 @ 1:18 PM
NCT ID: NCT02481206
Description: An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02481206
Study Brief: Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) 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
Wearable Cardioverter Defibrillator End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment. 0 None 0 29 5 29 View
Conventional Treatment Conventional treatment during hemodialysis initiation will be applied to this arm. 0 None 0 31 0 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Discomfort NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Frequent false alarms NON_SYSTEMATIC_ASSESSMENT Social circumstances None View