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: NCT00758420
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00758420
Study Brief: Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo agitated saline None None 1 38 19 38 View
Polidocanol Injectable Foam, 1.0% polidocanol injectable foam 1%, up to 15 mL, one treatment session None None 1 39 36 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
thrombectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
edema SYSTEMATIC_ASSESSMENT General disorders None View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
incision site hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hematoma evacuation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View