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: 2025-12-25 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT03929302
Description: It does not deviate from the definition mentioned in the clinical trials.gov
Frequency Threshold: 0
Time Frame: In period 1, the procedures administered carried minimal risk, henceforth no adverse events were noted. The subjects were followed for a period of 1 month during the assessments. In period 2, subjects were only followed during the period of interventions i.e., 6 weeks but not later than the time provided.
Study: NCT03929302
Study Brief: Brain Energy Metabolism and Sleep in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
myTAP Mouth Shield - Intervention to Improve Sleep and Cognition To investigate if MyTAP oral airway management with mouth shield will improve sleep and cognition in three cohorts: cognitively healthy adults, mild cognitive impairment, and Alzheimer's disease between the age of 55-85 years. MyTAP oral appliance plus mouth shield: The midline traction oral appliance (MyTAP, AMI Inc., Dallas, Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared will be used only in period -2 of the study. period -1 doesn't include any intervention. 0 None 0 18 0 18 View
Brain Energy Metabolism and Sleep on Cognition In the period -1 of the study, the investigator will be investigating the basic science of the relationship of sleep abnormalities, genes, brain energy metabolites variables with cognitive performance in three cohorts: cognitively normal adults, mild cognitive impairment, and Alzheimer's disease between the age of 55-85 years. 0 None 0 41 0 41 View
Serious Events(If Any):
Other Events(If Any):