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: 2025-12-25 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02041494
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected throughout the duration of the study, an average of 26 months.
Study: NCT02041494
Study Brief: Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Biologic Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Strattice 0 None 15 82 27 82 View
Synthetic Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene. SoftMesh/Ventralight ST 2 None 20 83 19 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
deep space infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
death SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
superficial SSI SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DVT/pumonary embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View