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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT02778867
Description: None
Frequency Threshold: 5
Time Frame: From informed consent to 30 days after the cessation of treatment
Study: NCT02778867
Study Brief: SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1-Food Elimination Diet (1FED) Participants eliminate milk from the diet in Phase 1 1 Food Elimination Diet Therapy 0 None 0 67 1 67 View
6-Food Elimination Diet (6FED) Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 6 Food Elimination Diet Therapy 0 None 0 62 2 62 View
1FED Non-Responders (6FED) Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 6 Food Elimination Diet (after 1FED failure) 0 None 0 21 0 21 View
6FED Non-responders (SGC) Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) 0 None 1 11 4 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bronchial Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View