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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT03320369
Description: None
Frequency Threshold: 5
Time Frame: From informed consent to cessation of treatment which is approximately 8 weeks
Study: NCT03320369
Study Brief: Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Elemental formula Intervention: Elemental Diet Therapy Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete 0 None 1 18 4 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Common Cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View