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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02587403
Description: Site reported adverse events
Frequency Threshold: 3
Time Frame: 2 years
Study: NCT02587403
Study Brief: A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Strattice™ Reconstructive Tissue Matrix Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia 5 None 23 60 23 60 View
Fortiva™ Porcine Dermis Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia 0 None 13 60 25 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seroma SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Wall Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial fibrillation with RVR SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Acute Respiratory Insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CHOLECOCHOLITHIASIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Endocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fluid Collection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fluid Overload SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyponatremia SYSTEMATIC_ASSESSMENT General disorders None View
Intra abdominal abscess SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intra abdominal fluid collection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Multisystem organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Partial small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PICC line infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Progressive Atherosclerotic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT General disorders None View
Recurrent GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory insufficiency SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Subcarinal mass with metastis to brain SYSTEMATIC_ASSESSMENT General disorders None View
Symptomatic bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Third degree AV block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Valve infection SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT General disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT General disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT General disorders None View
Hyphosphatemia SYSTEMATIC_ASSESSMENT General disorders None View
Itching SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Open wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post op pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View