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 @ 9:39 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT03328832
Description: None
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT03328832
Study Brief: Combined Topical Tranexamic Acid With Floseal® in Total 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
Combined Topical TXA and Floseal Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14. Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter) rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14. 0 None 0 35 17 35 View
Topical TXA Alone Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14. Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14. 0 None 0 34 15 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ecchymosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View