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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:33 AM
NCT ID: NCT03086018
Description: All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT03086018
Study Brief: A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Successor Hearing Aid to Juna The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks. 0 None 1 30 11 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to accident NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tore Meniscus NON_SYSTEMATIC_ASSESSMENT General disorders None View
Scratch on ear canal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dome in Ear NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sore Concha NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Back Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pressure point NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leg problem NON_SYSTEMATIC_ASSESSMENT General disorders None View
Face Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Irritation in ear NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tore Groin muscle NON_SYSTEMATIC_ASSESSMENT General disorders None View