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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT02573233
Description: Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to the end of Post-treatment period \[Week 24\]). Analysis was performed on safety population.
Frequency Threshold: 5
Time Frame: All AEs were collected from signature of the informed consent form up to the end of study (i.e. up to the end of Post-treatment period [Week 24]) regardless of seriousness or relationship to investigational medicinal product (IMP).
Study: NCT02573233
Study Brief: Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With 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
Dupilumab Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. 0 None 1 20 14 20 View
Placebo Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. 0 None 0 22 11 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Injection Site Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.1 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.1 View