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: 2025-12-26 @ 4:01 PM
Ignite Modification Date: 2025-12-26 @ 4:01 PM
NCT ID: NCT04225806
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT04225806
Study Brief: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Subjects will be treated with the investigational device and followed per protocol. BlueLeaf® Endovenous Valve Formation System (BlueLeaf System): The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated. 0 None 4 15 12 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding varicosity SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pressure SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal bruising SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Achilles tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Allergic reaction with blistering on skin SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Groin complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Animal Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthritis flare SYSTEMATIC_ASSESSMENT Immune system disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain post-procedure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion of right thigh SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Essential hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Indeterminate thrombus SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection at enoxaparin injection site SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection site reactions SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Left Lateral ankle venous ulcer infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leg cramps index leg SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bleeding at lovenox injection site SYSTEMATIC_ASSESSMENT General disorders None View
New venous ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in chest and arms (bilateral) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post procedure bleeding at access site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Posterior left knee soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Recurrent left ankle ulcer infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal stones with hydroureteronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right ankle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right thumb cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Right toe cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
ST depression SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tinnitus Left ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Valve Pocket Thrombus (VPT) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Venous ulcer infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening osteoarthritis left knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening ulceration relating to infection SYSTEMATIC_ASSESSMENT Infections and infestations None View