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 @ 12:40 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT04479761
Description: None
Frequency Threshold: 0
Time Frame: 2 weeks
Study: NCT04479761
Study Brief: Sensory Integration of Auditory and Visual Cues in Diverse Contexts
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vestibular Hypofunction Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI). 0 None 0 28 1 28 View
Unilateral Hearing Loss (UHL) Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear. 0 None 0 32 0 32 View
Healthy Controls Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org 0 None 0 41 0 41 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Tinnitus View