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: 2025-12-24 @ 12:50 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT00275561
Description: Safety was assessed with the side effect questionnaire at weeks 2 and 4 completed by a structured phone interview. The side effect questionnaire had questions on sore throat, hoarseness, white spots in the mouth, irritability, leg swelling, sleep disturbance, appetite change, acne, headache, diarrhea, nausea, and other new symptoms.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT00275561
Study Brief: Topical Steroid Treatment for Eosinophilic Esophagitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluticasone Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks None None 0 19 7 19 View
Placebo Placebo inhaler swallowed bid for 6 weeks None None 0 15 6 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sore throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Esophageal candidiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View