Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT05488535
Description: None
Frequency Threshold: 0
Time Frame: Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).
Study: NCT05488535
Study Brief: Non-significant Risk Study of a Cochlear Implant Headpiece
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-significant Risk Study of a Cochlear Implant Headpiece This arm aims to evaluate a cochlear implant headpiece. cochlear implant headpiece: investigational cochlear implant headpiece 0 None 2 101 5 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin Flap Thinning Procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device Temperature NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin Redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View