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 @ 3:55 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT05441592
Description: None
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT05441592
Study Brief: A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Irrigation that contains tranexamic acid (TXA) Tranexamic acid injection: The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes. 0 None 0 55 6 55 View
No additional irrigation usual care No additional irrigation: There will be no additional irrigation after the standard surgical procedure. 0 None 1 52 6 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hematoma Requiring Reoperation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgical site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Delayed wound healing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rash/Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View