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 @ 5:40 PM
Ignite Modification Date: 2025-12-25 @ 3:10 PM
NCT ID: NCT02912468
Description: Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 98 days). Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All Adverse Events (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 TEAE was up to 36 weeks.
Study: NCT02912468
Study Brief: A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
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), 1 SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose. 0 None 19 132 61 132 View
Dupilumab 300 mg Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose. 0 None 6 143 55 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 21.0 View
Aortic Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 21.0 View
Vitreous Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDra 21.0 View
Eosinophilic Granulomatosis With Polyangiitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 21.0 View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 21.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 21.0 View
Clavicle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 21.0 View
Foot Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 21.0 View
Anal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 21.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 21.0 View
Lumbar Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 21.0 View
Uterine Polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDra 21.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Chronic Rhinosinusitis With Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 21.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View
Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 21.0 View