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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT03021304
Description: AEs and SAEs were collected in All Subjects Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
Frequency Threshold: 3
Time Frame: On-treatment adverse events (AEs) and serious AEs (SAEs) were collected from time of study treatment administration (Week 0) up to Week 12
Study: NCT03021304
Study Brief: Study of Mepolizumab Safety Syringe in Asthmatics
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 Liquid Safety Syringe The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks. 0 None 3 56 4 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View