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 @ 3:22 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT03903692
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT03903692
Study Brief: A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous 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
Marine Polysaccharide Dressing Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver. 0 None 2 23 16 23 View
Carboxymethylcellulose Dressing Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels. 1 None 2 20 12 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
All-Cause Mortality NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View