Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:10 AM
NCT ID: NCT04607005
Description: The safety population included all randomized participants who received at least 1 dose of study treatment. On-treatment Adverse event (AEs) and serious adverse event (SAEs) occurred from first dose of mepolizumab to last dose of mepolizumab + 28 days inclusive.
Frequency Threshold: 3
Time Frame: From Day 1 (first dose) to Week 52
Study: NCT04607005
Study Brief: Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mepolizumab Participants received one dose of 100 mg/mL mepolizumab subcutaneous (SC) on top of Standard of Care (SoC) every 4 weeks during the 52-week treatment period. 0 None 0 84 47 84 View
Placebo Participants received one dose of matching placebo via SC route on top of SoC, every 4 weeks during the 52-week treatment period. 0 None 3 85 52 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Chronic rhinosinusitis with nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.0 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Immunisation reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Post vaccination fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.0 View