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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT04400318
Description: Analysis was performed on safety analysis set.
Frequency Threshold: 5
Time Frame: From first dose of study drug (Day 1) up to end of study (up to 36 weeks)
Study: NCT04400318
Study Brief: The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo matched to dupilumab as 2 x 2 mL SC injections on Day 1, followed by a single SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. 0 None 1 37 15 37 View
Dupilumab 300 mg Q2W Participants received a loading dose of dupilumab 600 mg as 2 SC injections on Day 1, followed by a single dupilumab 300 mg SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. 0 None 3 72 18 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 26.0 View
Eosinophilic Granulomatosis With Polyangiitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 26.0 View
Soft Tissue Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 26.0 View
Facial Bones Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 26.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 26.0 View
Sleep Apnoea Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 26.0 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 26.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.0 View