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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT03086135
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT03086135
Study Brief: Clinical Performance of a New Implant System for Bone Conduction Hearing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bone-conduction Hearing Device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet. Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea. 0 None 2 51 42 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infection and infestations SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Atrial fibrilation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
General disorders and administration site conditions other SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View