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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:48 PM
NCT ID: NCT03182751
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
Study: NCT03182751
Study Brief: Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tranexamic Acid Arm (TXA) Subjects will be treated with early administration of TXA in the Emergency Department Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours 7 None 8 64 0 64 View
Control Arm Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient 6 None 7 64 0 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep Vein Thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Embolism (PE) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Wound Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):