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 @ 2:23 AM
Ignite Modification Date: 2025-12-26 @ 12:55 AM
NCT ID: NCT02680834
Description: An adverse event (AEs) includes any complication whose clinical significance is greater than anticipated, or which occurs with a frequency greater than that which is usually seen for this type of device.
Frequency Threshold: 0
Time Frame: 16 Weeks
Study: NCT02680834
Study Brief: VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dual Action Pneumatic Compression Device ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks. Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs. 0 None 1 26 17 26 View
Multi-layer Bandaging PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks. Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs 0 None 2 30 12 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lumbar stenosis; spondylolisthesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain/Discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View