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 @ 4:38 PM
Ignite Modification Date: 2025-12-25 @ 2:28 PM
NCT ID: NCT05247866
Description: None
Frequency Threshold: 5
Time Frame: Enrollment until end of follow-up (up to 52 weeks)
Study: NCT05247866
Study Brief: Efficacy of Dupilumab on Facilitated Food Introduction in 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
Study Group 30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy) Dosing: \>12 years of age \> 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks 6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W \>30-60 kg 300 mg SQ Q2W 0 None 1 21 10 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Injection Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View