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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT04512703
Description: Adverse evenst were defined in the study as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects, users, or other persons whether or not related to the study device. Serious adverse events were defined per study protocol.
Frequency Threshold: 0
Time Frame: Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days.
Study: NCT04512703
Study Brief: Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Group Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days. µCor: Sensor Monitor for arrhythmia and other bio-metric markers 0 None 0 6 6 6 View
Arrhythmia Monitoring Group Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days. µCor: Sensor Monitor for arrhythmia and other bio-metric markers 0 None 0 45 42 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View