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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT01197833
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01197833
Study Brief: Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Endovenous Ablation, Vehicle Placebo Endovenous ablation followed by vehicle placebo None None 0 38 20 38 View
Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous ablation followed by polidocanol injectable foam, 0.5% None None 0 39 29 39 View
Endovenous Ablation, Polidocanol Injectable Foam 1.0% endovenous ablation followed by polidocanol injectable foam 1.0% None None 0 40 35 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
extravasation SYSTEMATIC_ASSESSMENT General disorders None View
infusion site thrombosis SYSTEMATIC_ASSESSMENT General disorders None View
edema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
tenderness SYSTEMATIC_ASSESSMENT General disorders None View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
excoriation 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
pain in extermity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders None View
thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View