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 @ 1:00 PM
Ignite Modification Date: 2025-12-25 @ 12:19 PM
NCT ID: NCT01312961
Description: Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'on treatment period' (time from first dose of investigatory medicinal product (IMP) up to the end of the follow-up period \[i.e. up to 7 weeks after the last dose of IMP\]).
Frequency Threshold: 5
Time Frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Study: NCT01312961
Study Brief: Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic 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 (for Dupilumab) Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks). 0 None 3 52 24 52 View
Dupilumab 300 mg qw Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks). 0 None 1 52 33 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinitis seasonal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View