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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT04599803
Description: Per Protocol: An Adverse Event (AE) is defined as any untoward medical occurrence, unintended disease or injury in subjects, users or other persons, that is considered a change from baseline or pre-study status, whether or not related to the investigational medical device.
Frequency Threshold: 0
Time Frame: Adverse events were collected during the entire duration of participation (232 Days). Reported Adverse Events were monitored through study completion.
Study: NCT04599803
Study Brief: Baseline Sleep Apnea Study #2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 Participants diagnosed with Obstructive Sleep Apnea (OSA) and provided a positive airway pressure (PAP) device. This was a single arm study of participants that are diagnosed with Obstructive Sleep Apnea (OSA) during the study. Upon confirmation of OSA and prescription of positive airway pressure (PAP) therapy, the participant began using the Verily Sleep Apnea (VSA) app to supplement PAP treatment. 0 None 1 105 14 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization subsequent to apparent syncopal event leading to chest wall injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Sore NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tooth Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue and sore throat due to COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Kidney Stone Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough due to COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory illness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough and upper respiratory symptoms due to COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever due to COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Congestion due to COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea/ Diarrhea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry nose/bloody nose due to weather NON_SYSTEMATIC_ASSESSMENT General disorders None View