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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:56 PM
NCT ID: NCT01051856
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected within the 90 day perioperative period.
Study: NCT01051856
Study Brief: TissueLink Versus SEAMGUARD After Distal Pancreatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SEAMGUARD With Bioabsorbable Staple SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device. None None 4 32 15 32 View
TissueLink With Radiofrequency Ablation TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm. None None 5 35 23 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital readmission for pancreatic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Percutaneous Drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pseudoaneurysm due to pancreatic fistula SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Intensive Care Unit or Progressive Care Unit Stay SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pancreatic fistula drainage longer than 3 weeks SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drained Amylase 3 Times Normal Upper Limit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Specific Treatment for Pancreatic Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatic Fistula Documented by X-Ray SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Postoperative Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View