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 @ 2:32 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT01937559
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from date of surgery to 6 month follow-up. All adverse events from the date of surgery to the final 6 month follow-up were assessed and collected for each patient.
Study: NCT01937559
Study Brief: Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Topical Tranexamic Acid (TXA) Topical Tranexamic acid (TXA) Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution 0 None 0 50 4 50 View
Saline Normal saline Normal saline 0 None 0 50 0 50 View
Intravenous Tranexamic Acid (TXA) Intravenous Tranexamic acid (TXA) 0 None 0 66 4 66 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ischemic stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View