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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT02066233
Description: Presenting adverse events per per intervention was not possible, as most patients were sedated prior to the procedures and only a few were not sedated. Therefore the adverse events were per patient population (study arm).
Frequency Threshold: 0
Time Frame: 2 weeks
Study: NCT02066233
Study Brief: Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subjects With Barrett's Esophagus All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. 0 None 0 44 44 44 View
Subjects With Reflux and/or Heartburn All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy. 0 None 0 44 44 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gagging/Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Choking SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Nasal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nose Bleed SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View