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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT02509260
Description: None
Frequency Threshold: 0
Time Frame: 30 days post surgery (+/- 7 days)
Study: NCT02509260
Study Brief: Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal 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
Prevena™ Incisional NPWT Prevena wound management system: Post op application of the Prevena™ wound management system will be applied. Prevena wound management system: Patients will have the Prevena wound management system applied post-operatively. 0 None 11 149 92 149 View
Standard Wound Dressings Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied. Standard wound dressings: Control patients with standard wound dressings will have gauze and tape dressings applied 1 None 19 149 84 149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abcess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bladder Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Portal Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Reoperation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
Bowel Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated Heart Rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Internal Bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ileostomy Ischemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ureteric Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory Insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Central Line bloodstream infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
High Ileostomy Output SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased Stoma output SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Drainage SYSTEMATIC_ASSESSMENT General disorders None View
Seroma/ Fluid Collection SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reoperation due to stoma kinking SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elevated White Blood Cells SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Short Gut Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
C. Diff SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal Separation SYSTEMATIC_ASSESSMENT General disorders None View
Blood Clots from Stoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lightheadness SYSTEMATIC_ASSESSMENT General disorders None View
Enteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gas SYSTEMATIC_ASSESSMENT General disorders None View
Placement/ replacement of Lines/ Tubes SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Leg Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Investigations None View
Pancreatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Wound Leak SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View