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 @ 6:44 PM
Ignite Modification Date: 2025-12-25 @ 4:15 PM
NCT ID: NCT04578457
Description: This study was a crossover design, therefore there was only a single study group. This group undertook measures under each of the study conditions. These conditions were undertaken in an interleaved fashion during the same study appointment. As such it is not possible to attribute the adverse event reported to any single condition. We therefore report the adverse events here as a function of the entire study population.
Frequency Threshold: 0
Time Frame: 7 months
Study: NCT04578457
Study Brief: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Cohort This study was a crossover design, therefore there was only a single study group. This group undertook measures under each of the study conditions. These conditions were undertaken in an interleaved fashion during the same study appointment. As such it is not possible to attribute the adverse event reported to any single condition. We therefore report the adverse events here as a function of the entire study population. 0 None 0 19 1 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Positive test for COVID-19 NON_SYSTEMATIC_ASSESSMENT General disorders None View