Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT01548404
Description: Reported adverse events (AEs) are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug through the end of study (Day 197).
Frequency Threshold: 5
Time Frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 197) regardless of seriousness or relationship to investigational product.
Study: NCT01548404
Study Brief: Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
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 Placebo (for Dupilumab) once weekly for 12 weeks by SC injection. None None 7 54 31 54 View
Dupilumab 300 mg Dupilumab 300 mg once weekly for 12 weeks by SC injection. None None 1 55 38 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Eczema herpeticum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (14.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (14.0) View
Asthmatic crisis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (14.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.0) View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (14.0) View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (14.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View