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 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT03912259
Description: TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Frequency Threshold: 5
Time Frame: All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks.
Study: NCT03912259
Study Brief: Evaluation of Dupilumab in Chinese Adult Patients With 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
Dupilumab 300 mg Q2W Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks. 0 None 1 82 56 82 View
Placebo Q2W Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks. 0 None 4 83 57 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.1 View
Connective Tissue Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Lung Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis Allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Blood Uric Acid Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Protein Urine Present SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View