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: 2025-12-26 @ 5:23 PM
Ignite Modification Date: 2025-12-26 @ 5:23 PM
NCT ID: NCT01651806
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01651806
Study Brief: Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee 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
Female Uniform Single Dose TA Patient Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing None None 1 13 0 13 View
Female Weighted Dose TA Patient Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing None None 1 12 1 12 View
Control Historical cohort of primary TKAs performed by BL, none of which received TA. None None 0 25 10 25 View
Male Uniform Single Dose TA Patient Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing None None 0 7 0 7 View
Male Weighted Dose TA Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing None None 0 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Symptomatic DVT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood Transfusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View