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 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT01013792
Description: Start at patient consent/screening, through 4-week run-in, through 8 weeks treatment, through 12 weeks post-treatment follow-up
Frequency Threshold: 5
Time Frame: 25 Weeks
Study: NCT01013792
Study Brief: A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-adherent Wound Dressing Wound Dressing: Acetate mesh carrier with ointment (water, PEGs) None None 1 14 6 14 View
Tegaderm Matrix Dressing With PHI Technology Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid) None None 3 16 11 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Subendocardial myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemic event with associate foot infection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ulcer/foot infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bladder Cancer SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory Disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wound/Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Phlebitis, Edema, Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Sprained ankle NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain, Trauma, Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bleeding NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Surgical resection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View