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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT04678856
Description: Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: TEAEs and TESAEs were collected from the first dose of study drug (Day 1) up to the last dose of study drug administration (373 days) + 98 days, up to 471 days. All-cause mortality (deaths) were collected from participant's screening (Day -28) to the end of follow-up for each participant, up to 476 days.
Study: NCT04678856
Study Brief: Dupilumab in CRSsNP
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 matching placebo via SC injection q2w for up to 53.2 weeks. 0 None 6 33 12 33 View
Dupilumab 300 mg q2w Participants received dupilumab 300 mg via SC injection q2w for up to 53.1 weeks. 0 None 3 38 20 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 26.1 View
Myocardial Bridging SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDra 26.1 View
Biloma SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 26.1 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 26.1 View
Chronic Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Foot Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 26.1 View
Spinal Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 26.1 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 26.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 26.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 26.1 View
Peripheral Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 26.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 26.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 26.1 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 26.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDra 26.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 26.1 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 26.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 26.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 26.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 26.1 View