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 @ 7:08 PM
Ignite Modification Date: 2025-12-25 @ 4:42 PM
NCT ID: NCT05873257
Description: None
Frequency Threshold: 0
Time Frame: 4 weeks (+/- 2 days)
Study: NCT05873257
Study Brief: Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg 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
Main Arm Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once per week. Biatain Fiber Ag applied to participants: Intervention involving a wound gelling fiber dressing with silver 0 None 1 50 8 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalised with pulmonary oedema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Antibiotics prescribed for study wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis (right hand) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased severe pain at wound site SYSTEMATIC_ASSESSMENT General disorders None View
Pain on removing dressing SYSTEMATIC_ASSESSMENT General disorders None View
Dressing adhered to the wound/painful SYSTEMATIC_ASSESSMENT General disorders None View