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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT01288612
Description: All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
Frequency Threshold: 0
Time Frame: 30 days after the procedure
Study: NCT01288612
Study Brief: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sedated Endoscopy Sedated esophagogastroduodenoscopy with biopsy Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl. None None 0 61 14 61 View
Transnasal Endoscopy at Hospital Unit Unsedated transnasal endoscopy at hospital unit. Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. None None 0 69 20 69 View
Transnasal Endoscopy at Mobile Unit Unsedated transnasal endoscopy in mobile research van Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure. None None 0 76 23 76 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epitaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nasal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal/chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View