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 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT02948959
Description: Reported AEs were treatment emergent AEs that developed/worsened in grade or became serious during during 'TEAE period' (from the time of first dose of study drug to the end of post-treatment period \[i.e., up to Week 64\]). Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All AEs were collected from signature of the informed consent form up to end of post treatment period (i.e., up to Week 64) regardless of seriousness or relationship to IMP.
Study: NCT02948959
Study Brief: Evaluation of Dupilumab in Children With Uncontrolled 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 Placebo (for Dupilumab), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64). 0 None 6 134 89 134 View
Dupilumab Dupilumab 200 mg (in 1.14 mL for \>30 kg BW) or 100 mg (in 0.67 mL for \<=30 kg BW), SC injection q2w for 52 weeks in combination with stable-dose background therapy of medium-dose ICS with a second controller medication (i.e., LABA, LAMA, LTRA or methylxanthines) or high-dose ICS alone or high-dose ICS with second controller medication. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Participants were followed up for 12 weeks after last dose (i.e. up to Week 64). 0 None 13 271 161 271 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Allergy To Chemicals SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Anaphylactic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Milk Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Immune Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Gastrointestinal Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lymphadenitis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Parainfluenzae Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Partial Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Injection Site Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View