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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT04823494
Description: One potential adverse effect was an adjustment of gain that could result in uncomfortable loudness. However, this was prevented automatically for all participants by limiting the maximum output of the devices. The app used to fit and control the device requires some familiarity with apps and the user may experience some frustration with these procedures initially. Adverse events and serious adverse events were monitored throughout the study for all participants. None were recorded.
Frequency Threshold: 0
Time Frame: The time from eligibility and baseline measures at Visit 1 through the completion of the outcome measures after the second wear period was 3-5 weeks. Adverse events were collected over this time frame for each participant.
Study: NCT04823494
Study Brief: Wear-Time Trial for Self-Fitting 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
Pro-Fit Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days. Hearing aids: Earbud style hearing aids fit to both ears 0 None 0 37 0 37 View
Self-Fit Hearing aids self-fit by participant and worn for 10-14 days. Hearing aids: Earbud style hearing aids fit to both ears 0 None 0 37 0 37 View
Serious Events(If Any):
Other Events(If Any):