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: 2025-12-24 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT04710368
Description: Final AE will be reported at 12 months, October 2023 data still being collected
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04710368
Study Brief: Effect of Evolocumab on Coronary Plaque Characteristics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Evolocumab subcutaneously administered 140 mg every 2 weeks for 26 weeks Evolocumab Injections: Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens. 2 None 5 110 30 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urgent Revascularization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Groin Pain SYSTEMATIC_ASSESSMENT Vascular disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nose bleed SYSTEMATIC_ASSESSMENT Vascular disorders None View
Papules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back/feet pain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Corneal abrasion SYSTEMATIC_ASSESSMENT Eye disorders None View
Cold/flu-like symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fever SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COVID SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain/tightness SYSTEMATIC_ASSESSMENT Cardiac disorders None View