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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT04998604
Description: Analysis was performed on the safety analysis set.
Frequency Threshold: 5
Time Frame: Serious adverse events (AEs) and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days. All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months
Study: NCT04998604
Study Brief: EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dupilumab 300 mg Q2W Participants received dupilumab 300 mg SC injection Q2W for 24 weeks. 0 None 3 179 48 179 View
Omalizumab 75 to 600 mg Q2W/Q4W Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks. 0 None 7 173 53 173 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eosinophilic Granulomatosis With Polyangiitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 27.1 View
Mycobacterium Avium Complex Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia Klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDra 27.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Neuroborreliosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Granulomatosis With Polyangiitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View