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: 2025-12-25 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT04577118
Description: Device related AEs and general AEs collected.
Frequency Threshold: 0
Time Frame: Surgery to 1 month post-operative
Study: NCT04577118
Study Brief: The iotaSOFT Insertion System Safety Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iotaSOFT Insertion System Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English 0 None 2 21 11 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Altered mental state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Patient hospitalization following knee surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Resistance with iotaSOFT NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Bruising and dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Incision coming open at CI site as seen at 2-week post-op visit. NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Swelling of face and eye area NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
No stimulation with device NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Drainage at implant site NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
CSF Leak NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain at incision NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Facial Stim NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View