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 @ 1:19 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT01027195
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01027195
Study Brief: Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip 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
Bipolar Radiofrequency Aquamantys 6.0 bipolar sealer \[Salient Surgical Technologies, Portsmouth, New Hampshire\] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (\<100 degrees Celsius) than standard Bovie electrocautery. None None 0 71 2 71 View
Standard Bovie Electrocautery Standard Bovie electrocautery \[Valleylab, Boulder, Colorado\] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels. None None 0 69 4 69 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coronary Ischemic Event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep-Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View