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: 2025-12-25 @ 1:28 AM
Ignite Modification Date: 2025-12-25 @ 11:40 PM
NCT ID: NCT01850394
Description: Perioperative venous thromboembolic complications * deep vein thrombosis screened with duplex doppler ultrasound in all cases * pulmonary embolism diagnosed with clinical hypoxemia and confirmed with computer tomography angiogram
Frequency Threshold: 0
Time Frame: 5 days
Study: NCT01850394
Study Brief: Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group physiologic saline 25 ml Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group None None 4 45 0 45 View
TXA-250 Group A total of 25-ml solution with 250-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure None None 1 45 0 45 View
TXA-500 Group A total of 25-ml solution with 500-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure None None 2 45 0 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Venous thromboembolic complication SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):