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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT03061903
Description: None
Frequency Threshold: 5
Time Frame: 90 days
Study: NCT03061903
Study Brief: Closed Incision Negative Pressure Therapy vs Standard of Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prevena Subjects will receive PREVENA after surgery. Prevena: Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days. Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device. 0 None 1 60 5 60 View
Aquacel Subjects will receive AQUACEL Ag after surgery. Aquacel: Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days. AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device. 0 None 0 60 11 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute periprosthetic joint infection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgical site complications SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View