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 @ 10:36 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT03465735
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
Study: NCT03465735
Study Brief: Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 0 None 0 8 7 8 View
Vascular Boot Group For each vascular boot session, the following data will be recorded: Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day Vascular Boot: The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 0 None 0 7 0 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Occlusive thrombi SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thoracic Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chemical Exposure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Left adnexal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View