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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT05139303
Description: The use of mandibular advancement devices for the management of obstructive sleep apnea are non invasive and reversible; adverse event data were not collected from the retrospective MAD group
Frequency Threshold: 0
Time Frame: From enrollment to the end of treatment at week 16. Participants were assessed every visit (every 2 weeks) from delivery of the mandibular advancement device until the end of follow up (week 16).
Study: NCT05139303
Study Brief: Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MAD Therapy Orthoapnea NOA®: The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: \> 50% reduction of AHI/RDI. Criterion II: AHI/RDI \< 5 events/hour or \<15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI \>5 events/hour with OSA associates symptoms. 0 None 0 33 1 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Jaw pain upon use of the mandibular advancement device SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View