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: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT04181320
Description: Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
Frequency Threshold: 0
Time Frame: Up to 20 weeks post baseline
Study: NCT04181320
Study Brief: A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Venous Leg Ulcer Standard of Care Subjects will recieve standard of care treatment. 0 None 3 66 6 66 View
Venous Leg Ulcer Standard of Care With Granulox Subjects will receieve standard of care treatment with Granulox added as an adjunct therapy. Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers. 0 None 2 62 7 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inflammation of left leg SYSTEMATIC_ASSESSMENT General disorders None View
Stroke (thrombotic) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Motor deficit of the lower limbs and mechanical fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT General disorders None View
Worsening of coronary artery disease (acute myocardial infarction) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Deterioration of basalioma on the face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Inflammation of left leg SYSTEMATIC_ASSESSMENT General disorders None View
Flu syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stasis dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Covid-19 infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Itching of the body SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View