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: 2025-12-25 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT05878093
Description: Analysis was performed on the safety population.
Frequency Threshold: 5
Time Frame: AEs, SAEs and all-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days
Study: NCT05878093
Study Brief: Dupilumab in Chinese Adult Participants With CRSwNP
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 placebo matched to dupilumab SC injection q2w from Day 1 up to 24 weeks. 0 None 0 32 11 32 View
Dupilumab 300 mg q2w Participants received dupilumab 300 mg SC injection q2w from Day 1 up to 24 weeks. 0 None 4 31 15 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 27.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Helicobacter Gastritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Endometrial Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra 27.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 27.1 View
Hepatic Steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 27.1 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 27.1 View